Cabotegravir + Rilpivirine

Drug information

Delivery device(s)

No delivery device

Scale-up prospects

Compounds are commercially manufactured.

Tentative equipment list for manufacturing

Conventional wet-bead milling apparatus (e.g. Netzsch ball mill), depyrogenated glass vials, high pressure homogenizer.

Manufacturing

Cabotegravir and Rilpivirine are formulated into a wet-mill suspension of approximately 200mg/ml and 300mg/ml respectively, due to their low aqueous solubility. This formulation results in the creation of nanocrystal drug particles which are amenable for intramuscular gluteal depot injection. The manufacturing process for RPV is considered to be non-standard due to the inclusion of an aseptic processing step. RPV is light-sensitive, and exposure to light can induce conversion into a Z-isomer form which can affect pharmacokinetic data and activity.

Specific analytical instrument required for characterization of formulation

PANalytical X’Pert PRO diffractometer equipped with a theta/theta coupled goniometer (or equivalent x-ray powder diffractor), Mettler TGA/DSC 1 instrument for thermal analysis, Laser diffractor (determine particle size), FT-IR UHPLC (chemical identification), UHPLC (chromatographic purity), paddle apparatus & UPLC/UV (determine in-vitro drug release for QC / dissolution testing).

POLAR

Identifier

NCT03639311

Link

https://clinicaltrials.gov/study/NCT03639311

Phase

Phase II

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-09-24

Anticipated Date of Last Follow-up
2024-05-13

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2019-12-11

Actual Completion Date
2023-01-30

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than [<]50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval).

Health status

Study type

Interventional (clinical trial)

Enrollment

97

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.

Masking

Open label

Masking description

This is an open-label study, thus no masking.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CUSTOMIZE

Identifier

NCT04001803

Link

https://clinicaltrials.gov/study/NCT04001803

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-07-08

Anticipated Date of Last Follow-up
2023-03-16

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2020-10-05

Actual Completion Date
2022-03-18

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: - Aged 18 years or older at the time of signing the informed consent. - HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) regimen for at least 6 months prior to Screening. - Be able to understand and comply with protocol requirements, instructions, and restrictions. - Understand the long-term commitment to the study and be likely to complete the study as planned. - Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications.

Health status

Study type

Interventional (clinical trial)

Enrollment

115

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CR109089

Identifier

NCT05112939

Link

https://clinicaltrials.gov/study/NCT05112939

Phase

Phase I

Status

Completed

Sponsor

Janssen Research & Development, LLC

More details

Not provided

Purpose

Characterize the single dose pharmacokinetics and evaluate the safety and tolerability of subcutaneous administration of RPV LA in combination with CAB LA in different conditions in healthy adults.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-16

Anticipated Date of Last Follow-up
2025-02-27

Estimated Primary Completion Date
2024-05-23

Estimated Completion Date
2024-05-23

Actual Primary Completion Date
2024-05-23

Actual Completion Date
2024-05-23

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG).

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

126

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Single blind masking

Masking description

Single (Participant)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ATLAS-2M

Identifier

NCT03299049

Link

https://clinicaltrials.gov/study/NCT03299049

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine in HIV-1-infected Adults Who Are Virologically Suppressed.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-10-27

Anticipated Date of Last Follow-up
2024-12-10

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-12-31

Actual Primary Completion Date
2019-06-06

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: - Subjects who will be able to understand and comply with protocol requirements, instructions, and restrictions. - Understand the long term commitment to the study and be likely to complete the study as planned. - Be considered as an appropriate candidate for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). - Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.

Health status

Study type

Interventional (clinical trial)

Enrollment

1049

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Two groups of subjects will be randomized to receive CAB LA + RPV LA Q4W, or CAB LA + RPV LA Q8W regimen.

Masking

Open label

Masking description

This will be an open-label study and therefore no blinding is required.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SOLAR

Identifier

NCT04542070

Link

https://clinicaltrials.gov/study/NCT04542070

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-11-09

Anticipated Date of Last Follow-up
2024-06-03

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-07-13

Actual Completion Date
2023-04-17

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: - Participants aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent. - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization). - Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Health status

Study type

Interventional (clinical trial)

Enrollment

687

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ATLAS

Identifier

NCT02951052

Link

https://clinicaltrials.gov/study/NCT02951052

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Establish if HIV-1 infected adult subjects with current viral suppression on a regimen with 2 NRTIs plus a third agent, remain suppressed upon switching to a 2 drug intramuscular regime of CAB/RPV-LA.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-10-28

Anticipated Date of Last Follow-up
2025-01-09

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-12-31

Actual Primary Completion Date
2018-05-29

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Must be on uninterrupted current ARV regimen (either the initial or second ARV regimen) for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA ≥400 c/mL).

Health status

Study type

Interventional (clinical trial)

Enrollment

618

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

FLAIR

Identifier

NCT02938520

Link

https://clinicaltrials.gov/study/NCT02938520

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Establish if HIV-1 infected adult participants whose virus is virologically suppressed on an INI STR will remain suppressed after switching to a two drug LA regimen of CAB and RPV.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-10-27

Anticipated Date of Last Follow-up
2025-03-04

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-12-31

Actual Primary Completion Date
2018-08-30

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Antiretroviral-naive (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.

Health status

Study type

Interventional (clinical trial)

Enrollment

631

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARISEL

Identifier

NCT04399551

Link

https://clinicaltrials.gov/study/NCT04399551

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-09-28

Anticipated Date of Last Follow-up
2024-04-04

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-03-07

Actual Completion Date
2023-03-13

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

HIV-1 infected and must be suppressed on a guideline recommended active Highly active antiretroviral therapy (HAART) regimen for at least 6 months prior to screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for virologic failure (on treatment HIV-1 RNA more than or equal to [>=]200 c/mL).

Health status

Study type

Interventional (clinical trial)

Enrollment

437

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

This is an open-label study hence no blinding is required.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LATA

Identifier

NCT05154747

Link

https://clinicaltrials.gov/study/NCT05154747

Phase

Phase III

Status

Active, not recruiting

Sponsor

University College, London

More details

Not provided

Purpose

Comparing the efficacy of long-acting injectable CAB+RPV administered every two months in comparison to daily oral HIV medications in young people.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-06-22

Anticipated Date of Last Follow-up
2024-04-26

Estimated Primary Completion Date
2025-03-01

Estimated Completion Date
2026-03-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adolescents
• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Study participants are individuals with HIV-1 infection aged 12-19 years in Sub-Saharan Africa. Participants with known HIV-2 infection are excluded.

Health status

Study type

Interventional (clinical trial)

Enrollment

476

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IMPALA

Identifier

NCT05546242

Link

https://clinicaltrials.gov/study/NCT05546242

Phase

Phase III

Status

Active, not recruiting

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit

More details

Not provided

Purpose

Evaluating the Effectiveness of Switching to Two-monthly Long-acting Injectable CAB and RPV From First-line Oral Antiretroviral Therapy in HIV-1 Positive Virologically Suppressed Adults in SSA.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-12-08

Anticipated Date of Last Follow-up
2024-09-25

Estimated Primary Completion Date
2025-04-01

Estimated Completion Date
2026-03-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants must have a history of sub-optimal ART adherence or engagement in care based on one or more of the following criteria: 1. Documented detectable HIV-1 VL (>1000 c/mL) on all-oral ART (EFV/NVP or DTG-based) in the prior 2 years despite being ART-experienced for ≥3 months. 2. History of being lost to follow-up from care (>4 weeks elapsed since a missed scheduled clinic appointment or refill in the prior 2 years). 3. Failed to link to HIV care despite ≥3 months elapsed since HIV diagnosis.

Health status

Study type

Interventional (clinical trial)

Enrollment

540

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Parallel open-label phase 3b study. Participants will be randomised to continuing current therapy or switching to injectable therapy.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LATITUDE

Identifier

NCT03635788

Link

https://clinicaltrials.gov/study/NCT03635788

Phase

Phase III

Status

Active, not recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

Not provided

Purpose

Compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-03-28

Anticipated Date of Last Follow-up
2025-04-22

Estimated Primary Completion Date
2024-09-30

Estimated Completion Date
2026-08-30

Actual Primary Completion Date
2024-02-12

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Evidence of non-adherence to ART according to at least one of the following criteria: 1. Poor virologic response within 18 months prior to study entry (defined as less than 1 log10 decrease in HIV-1 RNA or HIV-1 RNA greater than 200 copies/mL at two time points at least 4 weeks apart) in individuals who have been prescribed ART for at least 6 consecutive months. 2. Lost to clinical follow-up within 18 months prior to study entry with ART non-adherence for greater than or equal to 6 consecutive months.

Health status

Study type

Interventional (clinical trial)

Enrollment

456

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LATTE-2

Identifier

NCT02120352

Link

https://clinicaltrials.gov/study/NCT02120352

Phase

Phase II

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the antiviral activity, tolerability, and safety of IM dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 plus ABC/3TC given orally once daily, in ARV naïve HIV-1 patients.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2014-04-28

Anticipated Date of Last Follow-up
2024-06-11

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2015-08-13

Actual Completion Date
2023-04-20

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants must be ART-naïve defined as having no more than 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection.

Health status

Study type

Interventional (clinical trial)

Enrollment

309

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

NCT04371380

Identifier

NCT04371380

Link

https://clinicaltrials.gov/study/NCT04371380

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate pharmacokinetics, tolerability, and safety of Cabotegravir long acting plus Rilpivirine long acting administered concomitantly as two separate IM injections in the Vastus Lateralis muscles.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-09-16

Anticipated Date of Last Follow-up
2023-11-03

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2021-12-26

Actual Completion Date
2021-12-26

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Participants aged 18 to 50 who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Health status

Study type

Interventional (clinical trial)

Enrollment

15

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Eligible participants will receive orally, tablets of cabotegravir plus rilpivirine for 28 days. There will be 10 to 14 days wash out period followed by an IM injection of cabotegravir long-acting plus rilpivirine long-acting.

Masking

Open label

Masking description

This is an open label study.

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LAI115428

Identifier

NCT01593046

Link

https://clinicaltrials.gov/study/NCT01593046

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2012-05-01

Anticipated Date of Last Follow-up
2014-02-06

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2013-11-01

Actual Completion Date
2013-11-01

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Healthy as determined by a responsible and experienced physician. - Male or female between 18 and 64 years of age inclusive, at the time of signing the informed consent. - Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive). - All Study subjects should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).

Health status

Study type

Interventional (clinical trial)

Enrollment

43

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Unspecified

Key resources

CAPRI

Identifier

NCT05601128

Link

https://clinicaltrials.gov/study/NCT05601128

Phase

Phase III

Status

Completed

Sponsor

Allegheny Singer Research Institute

More details

Not provided

Purpose

Evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-01-01

Anticipated Date of Last Follow-up
2025-02-06

Estimated Primary Completion Date
2025-04-01

Estimated Completion Date
2025-12-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants are positive for HIV infection and severe renal impairment with or without hemodialysis.

Health status

Study type

Interventional (clinical trial)

Enrollment

12

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

MOCHA

Identifier

NCT03497676

Link

https://clinicaltrials.gov/study/NCT03497676

Phase

Phase I/II

Status

Active, not recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

Not provided

Purpose

Evaluate the safety, acceptability, tolerability, and pharmacokinetics of oral and long-acting injectable CAB and RPV in virologically suppressed HIV-infected children and adolescents.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-04-03

Anticipated Date of Last Follow-up
2024-09-03

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-06-17

Actual Primary Completion Date
2023-02-18

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adolescents

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

168

Allocation

Non-randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VOLITION

Identifier

NCT05917509

Link

https://clinicaltrials.gov/study/NCT05917509

Phase

Phase III

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the efficacy, safety, implementation effectiveness, and patient-reported outcomes of once-daily oral DTG/3TC followed by an optional participant-determined switch to CAB/RPV-LA.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-07-28

Anticipated Date of Last Follow-up
2025-05-13

Estimated Primary Completion Date
2025-09-03

Estimated Completion Date
2026-09-03

Actual Primary Completion Date
2026-01-30

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Antiretroviral-naïve participants (defined as no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) prior to enrolment with plasma HIV-1 RNA ≥1,000 c/mL at screening. Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

Health status

Study type

Interventional (clinical trial)

Enrollment

171

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ALADDIN

Identifier

NCT06468995

Link

https://clinicaltrials.gov/study/NCT06468995

Phase

Phase III

Status

Recruiting

Sponsor

IRCCS San Raffaele

More details

This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients. Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.

Purpose

Antiviral Long Acting Drugs Landing in People Living With HIV

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-09-01

Actual Start Date
2024-12-02

Anticipated Date of Last Follow-up
2024-12-04

Estimated Primary Completion Date
2026-03-01

Estimated Completion Date
2026-11-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV; - Aged 18 years or older at the time of signing the informed consent. - People willing to switch to long-acting therapy - On a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA \<50 copies/ml): - Documented evidence of plasma HIV-1 RNA measurements \<50 c/mL in the 6 months prior to Screening. - Plasma HIV-1 RNA \<50 c/mL at Screening. - Ability to understand informed consent form and other relevant regulatory documents.

Health status

Study type

Interventional (clinical trial)

Enrollment

120

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CROWN

Identifier

NCT06694805

Link

https://clinicaltrials.gov/study/NCT06694805

Phase

Phase III

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Purpose

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-12-02

Anticipated Date of Last Follow-up
2025-02-18

Estimated Primary Completion Date
2026-05-13

Estimated Completion Date
2027-12-08

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Age 1. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent). * Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL. 3.Plasma HIV-1 RNA \>1 000 c/mL and greater than (\<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.\<1 log10 decrease in HIV-1 RNA or HIV-1 RNA \>200 c/

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

332

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Not provided

Use case

Not provided

Key resources

PANNA

Identifier

NCT00825929

Link

https://clinicaltrials.gov/study/NCT00825929

Phase

Marketed

Status

Recruiting

Sponsor

Radboud University Medical Center

More details

Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.

Purpose

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2009-02-01

Anticipated Date of Last Follow-up
2025-01-10

Estimated Primary Completion Date
2026-12-01

Estimated Completion Date
2026-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Female

Accepts pregnant individuals
Yes

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

HIV-infected pregnant women using at least one of the following antiretroverial agents: Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir; cabotegravir/rilpivirine LA

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

176

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

ILANA

Identifier

NCT05294159

Link

https://clinicaltrials.gov/study/NCT05294159

Phase

Marketed

Status

Completed

Sponsor

Queen Mary University of London

More details

This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.

Purpose

Implementing Long-Acting Novel Antiretrovirals

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-07-18

Anticipated Date of Last Follow-up
2024-07-04

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-12-22

Actual Completion Date
2023-12-22

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All
• Male
• Female
• Cisgender female
• Cisgender male
• Transgender female
• Transgender male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Study type

Not provided

Enrollment

114

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SUPLA

Identifier

NCT06507059

Link

https://clinicaltrials.gov/study/NCT06507059

Phase

Phase III

Status

Recruiting

Sponsor

Chang Gung Memorial Hospital

More details

This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.

Purpose

Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-07-19

Anticipated Date of Last Follow-up
2024-08-21

Estimated Primary Completion Date
2025-07-01

Estimated Completion Date
2026-12-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Willing to sign the written informed consent form for male and female participants aged 18 and above. * At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months. * Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL. * Body weight ≥ 35Kg. * Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends). * Willing to receive gluteal (buttocks) drug injections. * Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinua

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

40

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

GLACIER

Identifier

NCT04982445

Link

https://clinicaltrials.gov/study/NCT04982445

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting \[LA\] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.

Purpose

Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-18

Anticipated Date of Last Follow-up
2025-03-18

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2024-01-31

Actual Completion Date
2024-01-31

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria * Adults (greater than or equal to \[\>=\]18 years old) at the time of signing the informed consent. * HIV-1 infected and have been prescribed CABNEUVA per the United States Prescribing information (USPI). * Participants can be enrolled * If they have been taking oral VOCABRIA + EDURANT or other ART for approximately 1 month (at least 28 days) prior to Baseline/Month 1, or * Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the USPI, or * Prescribed direct to inject and receive their 1st injection without an oral lead in at the Infu

Health status

Study type

Interventional (clinical trial)

Enrollment

44

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

The Cheeky Study

Identifier

NCT05979714

Link

https://clinicaltrials.gov/study/NCT05979714

Phase

Marketed

Status

Active, not recruiting

Sponsor

Public Health Foundation Enterprises, Inc.

More details

This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.

Purpose

The Cheeky Study: A Novel Delivery System for CAB-RPV LA

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-05-31

Anticipated Date of Last Follow-up
2024-08-01

Estimated Primary Completion Date
2024-12-01

Estimated Completion Date
2024-12-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Age 18 years or older * Male sex at birth and gender identity other than male * Willing and able to provide written informed consent * HIV-infected, confirmed by laboratory testing (can be via medical record) * Eligible to receive CAB-RPV LA per FDA-approved label * Virologically suppressed at the last visit within the last 6 months (HIV RNA \<50 copies/ml) * Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV * Currently receiving HIV care by a care provider at one of the collaborating primary care clinics. * Has a cell phone and active service * Able to understand, read, and speak English Exclusion Criteria: * Unable to receive gluteal injections * Plans to move away from the site area within the next 9 months. *

Health status

Study type

Interventional (clinical trial)

Enrollment

50

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Not provided

Use case

Not provided

Key resources

CHEERS

Identifier

NCT06565013

Link

https://clinicaltrials.gov/study/NCT06565013

Phase

Marketed

Status

Not yet recruiting

Sponsor

Clinique Médicale L'Actuel

More details

CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB + RPV LA after being virologically suppressed on a stable oral ART regimen. This study aim to assess the impact of increased patient engagement associated with this LA regimen on linkage to psychosocial care and on global health outcomes, such as quality of life, substance use, treatment satisfaction and virological control. Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB + RPV LA. The participants will be followed in this study for 11 months from their first LA administration, according to the schedule of injections. In addition to standard of care procedures, such as blood

Purpose

Chemsex Health Evaluation With Extended Release System for HIV Treatment

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-08-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-08-19

Estimated Primary Completion Date
2026-02-01

Estimated Completion Date
2026-02-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Study type

Not provided

Enrollment

50

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARLA

Identifier

NCT05156658

Link

https://clinicaltrials.gov/study/NCT05156658

Phase

Marketed

Status

Withdrawn

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

More details

The purpose of this pharmacokinetic (PK) trial is to evaluate whether the ENG implant, a long-acting birth control method, is tolerable and effective for adults with HIV who are taking long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA). Access to safe and effective birth control for adults with HIV is important because it may result in fewer infants exposed to HIV in the womb or born with HIV. Researchers believe that people of childbearing potential need access to birth control options that do not need to be negotiated with a partner.

Purpose

Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA)

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-01-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-12-10

Estimated Primary Completion Date
2024-08-02

Estimated Completion Date
2024-08-02

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Last menstrual period started ≤35 days prior to study entry. If the start of the last menstrual period was \>35 days prior to study entry, and the individual has been using hormonal contraception for at least 30 days prior to study entry, individual is eligible. If the start of the last menstrual period was \>35 days prior to study entry, and the individual has not been using hormonal contraception for at least 30 days prior to study entry, serum follicle-stimulating hormone (FSH) must be ≤40 mIU/mL. * Negative serum or urine pregnancy test (urine test must have a sensitivity of ≤25 mIU/mL) within 48 hours prior to study entry by any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or is using a poi

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Not provided

Use case

Treatment

Key resources

JABS

Identifier

ACTRN12622000105741

Link

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383336

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

Open label, single arm interventional clinical trial of long acting cabotegravir 600mg and long acting rilpivirine 900mg administered by intramuscular injections every two months for a total of 12 months in subjects on standard of care oral regimens, including those with complex medical and social vulnerability factors. Adherence with treatment will be monitored using records of clinic attendance and administration of injections.

Purpose

Feasibility and effectiveness of long acting cabotegravir and rilpivirine for treatment of HIV infection in patients with complex needs.

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-02-10

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-05-25

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Male
• Female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

• Aged 18 years or older at the time of signing the informed consent. • Have HIV infection treated with a standard combination antiretroviral regimen for at least 6 months prior to screening. • Documented evidence of at least one plasma HIV-1 RNA measurement <40 cps/mL in the 24 weeks prior to screening and within 4 weeks of enrolment. • A female participant with reproductive potential but using acceptable forms of contraception is eligible to participate

Health status

Study type

Not provided

Enrollment

Not provided

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EMPOWER (GS-US-380-6738)

Identifier

NCT06104306

Link

https://clinicaltrials.gov/study/NCT06104306

Phase

Marketed

Status

Completed

Sponsor

Gilead Sciences

More details

The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

Purpose

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-12-13

Anticipated Date of Last Follow-up
2025-05-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-01-29

Actual Completion Date
2025-04-23

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Key Inclusion Criteria: * People with HIV-1 (PWH) or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily B/F/TAF * Currently virologically suppressed (HIV-1 RNA \< 50 copies/mL) on CAB+RPV IM injections every 2 months * Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections * Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV * Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit * No documented or suspected resistance to BIC, emtricitabine (FTC), or tenofovir (TFV). Key Exclusion Criteria: * History of B/F/

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

33

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IMPAACT 2036

Identifier

NCT05660980

Link

https://clinicaltrials.gov/study/NCT05660980

Phase

Phase I/II

Status

Recruiting

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

Purpose

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-01-24

Anticipated Date of Last Follow-up
2025-05-23

Estimated Primary Completion Date
2026-06-15

Estimated Completion Date
2027-07-27

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b * Parent or legal guardian is willing and able to provide written permission for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation. Note: All sites must follow all applicable IRB/EC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures. * Age two years old to less than 12 years old at entry * Body weight ≥10 kgs and \<40 kgs at entry * At entry, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee. * Confirmed HIV-1-infection based on do

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

90

Allocation

Not provided

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CREATE

Identifier

NCT06062979

Link

https://clinicaltrials.gov/study/NCT06062979

Phase

Marketed

Status

Enrolling by invitation

Sponsor

Whitman-Walker Institute

More details

The purpose of this study is to assess adherence to home-delivered long-acting injectable rilpivirine/cabotegravir (Cabenuva) among people living with HIV enrolled in the Mobile Outreach Retention and Engagement (MORE) program at Whitman-Walker Health due to significant barriers to being retained in care; the MORE program provides supportive services including dedicated care navigation, transportation assistance, and mobile/home-delivered care. The investigators will examine the equivalence of treatment outcomes among patients receiving injectable treatment within the MORE program as compared to those of patients receiving Cabenuva in standard care at Whitman-Walker Health.

Purpose

Clinical Effectiveness-Implementation Hybrid Type 2 Study on Home-Delivered Cabenuva for People Living With HIV Who Are Not Retained in Care

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-01

Anticipated Date of Last Follow-up
2024-04-23

Estimated Primary Completion Date
2025-06-30

Estimated Completion Date
2025-06-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

180

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EXPAND

Identifier

NCT06635421

Link

https://clinicaltrials.gov/study/NCT06635421

Phase

Marketed

Status

Not yet recruiting

Sponsor

MetroHealth Medical Center

More details

The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.

Purpose

The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-11-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-10-08

Estimated Primary Completion Date
2026-12-31

Estimated Completion Date
2026-12-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

164

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Non-Probability Sample

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARES

Identifier

PACTR202104874490818

Link

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15757

Phase

Marketed

Status

Active, not recruiting

Sponsor

Joint Clinical Research Centre, Kampala, Uganda

More details

Primary objective: To demonstrate the non-inferior antiviral activity of switching to IM RPV LA+CAB LA administered every 2 months compared with continuation of cART administered daily over 12 months in HIV-1 infected participants in a resource limited setting Secondary objectives: 1. To demonstrate the antiviral and immunologic activity of switching to IM RPV LA+CAB LA every 2 months compared to continuation of cART over 12 and 24 months of follow-up. 2. To evaluate the safety and tolerability of switching to RPV LA+CAB LA every 2 months compared to continuation of cART. 3. To assess viral resistance in participants experiencing protocol-defined confirmed virologic failure(plasma HIV-1 RNA ≥200 c/mL). 4. To assess the incidence of on-treatment genotypic resistance to CAB, RPV and other on

Purpose

Cabotegravir And Rilpivirine: Efficacy and Safety Study (CARES)

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-09-15

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2024-08-20

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

512

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

HOLA

Identifier

NCT06185452

Link

https://clinicaltrials.gov/study/NCT06185452

Phase

Marketed

Status

Completed

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

More details

HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

Purpose

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-09-26

Anticipated Date of Last Follow-up
2025-07-09

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-05-30

Actual Completion Date
2025-05-30

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Patients equal or older than 18 years old 2. Chronic HIV infection 3. HIV patients in whom LA CAB+RPV is prescribed 4. Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA. 5. Virologically suppression for at least 6 months: 2 consecutive determinations of undetectable viral load (plasma HIV-1 RNA levels \< 50 copies/ml ) for ≥ 6 months preceding the study randomization. 6. Post-menopausal or fertile females that agree to avoid pregnancy during the study. If sexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first IMP administration until at least 13 months after the last Investigational Medicinal Produ

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

103

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

OPERA

Identifier

Not provided

Link

https://cabenuvahcp.com/real-world-evidence/opera-efficacy-and-safety/

Phase

Marketed

Status

Recruiting

Sponsor

ViiV Healthcare

More details

Real-world evidence from OPERA reinforces results from SOLAR. This large, representative real-world study supports the effectiveness and practicality of long-acting CAB+RPV LA (CABENUVA) for both virologically suppressed and select viremic populations in routine care.

Purpose

OPERA is a real-world study of adult participants who switched to CABENUVA or a new oral ART regimen

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-01-21

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
2023-06-30

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

ART-experienced, predominantly virologically suppressed (<50 copies/mL), but included some with viremia

Health status

Study type

Not provided

Enrollment

3300

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Non-interventional cohort study; adult HIV patients switched from daily oral ART to CAB+RPV LA (CABENUVA)

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

BEYOND

Identifier

Not provided

Link

https://cabenuvahcp.com/real-world-evidence/beyond-efficacy-and-safety/

Phase

Marketed

Status

Recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

real-world, prospective, observational study conducted to evaluate the use, adherence, and outcomes of long-acting cabotegravir plus rilpivirine (CAB+RPV LA) injections in adults with HIV.

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-06-01

Anticipated Date of Last Follow-up
2024-06-01

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-03-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

Not provided

Allocation

Non-randomized

Intervention model

Not provided

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CARLOS

Identifier

Not provided

Link

https://medinfo.gsk.com/5f95dbd7-245e-4e65-9f36-1a99e28e5bba/543bb60f-36ea-4795-978f-fc77dc7cc6ca/543bb60f-36ea-4795-978f-fc77dc7cc6ca_viewable_rendition__v.pdf

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate effectiveness, adherence, and patient-reported outcomes for CAB+RPV LA Q2M in routine care

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2022-02-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
2023-11-20

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
2025-02-01

Studied populations

Age Cohort

• Adults

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Study type

Not provided

Enrollment

Not provided

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

20241441

Identifier

NCT06704204

Link

https://clinicaltrials.gov/study/NCT06704204

Phase

Marketed

Status

Not yet recruiting

Sponsor

The Miriam Hospital

More details

The federal research award entitles "Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community" aims to Conduct interviews with justice and treatment experienced PWH (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral ART to LAI ART in prison with continuation during community re-entry; develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 20-30 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including par

Purpose

Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2025-02-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2025-01-13

Estimated Primary Completion Date
2025-07-31

Estimated Completion Date
2025-07-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

20

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CROWN

Identifier

NCT06694805

Link

https://clinicaltrials.gov/study/NCT06694805

Phase

Phase III

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Purpose

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-12-02

Anticipated Date of Last Follow-up
2025-06-16

Estimated Primary Completion Date
2026-05-13

Estimated Completion Date
2027-12-08

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Age 1. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent). * Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL. 3.Plasma HIV-1 RNA \>1 000 c/mL and greater than (\<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.\<1 log10 decrease in HIV-1 RNA or HIV-1 RNA \>200 c/

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

332

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

LOVER60

Identifier

NCT06646562

Link

https://clinicaltrials.gov/study/NCT06646562

Phase

Marketed

Status

Recruiting

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

More details

People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients

Purpose

Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-03-03

Anticipated Date of Last Follow-up
2025-03-06

Estimated Primary Completion Date
2026-01-30

Estimated Completion Date
2027-01-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Be able to understand and comply with protocol requirements, instructions, and restrictions. * Understand the long-term commitment to the study and be likely to complete the study as planned. * Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). * Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. * Plasma HIV-1 RNA \<50 copies/mL at screening. * A female subject is eligible to participate if she is not pregnant (as confirmed b

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

120

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

HOLA 2

Identifier

NCT06643897

Link

https://clinicaltrials.gov/study/NCT06643897

Phase

Marketed

Status

Completed

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

More details

The study will identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the study.

Purpose

Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-07-16

Anticipated Date of Last Follow-up
2025-01-29

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2024-10-23

Actual Completion Date
2024-10-23

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Participation throughout the HOLA study until the moment of conducting the interviews and direct involvement in the study procedures in a significant way. 2. Homogeneous sample between the different roles participating in the study. 3. Participants who agree to participate in the substudy and sign the informed consent. Exclusion Criteria: NONE

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

13

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EXPAND

Identifier

NCT06635421

Link

https://clinicaltrials.gov/study/NCT06635421

Phase

Marketed

Status

Not yet recruiting

Sponsor

MetroHealth Medical Center

More details

The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.

Purpose

The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-11-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-10-08

Estimated Primary Completion Date
2026-12-31

Estimated Completion Date
2026-12-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

164

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CHEERS

Identifier

NCT06565013

Link

https://clinicaltrials.gov/study/NCT06565013

Phase

Marketed

Status

Not yet recruiting

Sponsor

Clinique Médicale L'Actuel

More details

CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB + RPV LA after being virologically suppressed on a stable oral ART regimen. This study aim to assess the impact of increased patient engagement associated with this LA regimen on linkage to psychosocial care and on global health outcomes, such as quality of life, substance use, treatment satisfaction and virological control. Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB + RPV LA. The participants will be followed in this study for 11 months from their first LA administration, according to the schedule of injections. In addition to standard of care procedures, such as blood

Purpose

Chemsex Health Evaluation With Extended Release System for HIV Treatment

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-08-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-08-19

Estimated Primary Completion Date
2026-02-01

Estimated Completion Date
2026-02-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

50

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CABO-CHANCE

Identifier

NCT06518408

Link

https://clinicaltrials.gov/study/NCT06518408

Phase

Marketed

Status

Active, not recruiting

Sponsor

University Hospital Virgen de las Nieves

More details

The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.

Purpose

A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-06-01

Anticipated Date of Last Follow-up
2024-07-23

Estimated Primary Completion Date
2026-04-30

Estimated Completion Date
2027-09-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

287

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IM-CAPABLE

Identifier

NCT06451341

Link

https://clinicaltrials.gov/study/NCT06451341

Phase

Marketed

Status

Recruiting

Sponsor

University of Nebraska

More details

The goal of this implementation science study is to learn about the experience of receiving and providing cabotegravir + rilpivirine long-acting (CAB+RPV LA) injections as treatment for human immunodeficiency virus (HIV) for people who live a significant distance from an HIV provider. The main questions it aims to answer are: * Is CAB+RPV LA feasible and acceptable to patients and staff? * What barriers and supports exist and have the most impact on receiving and providing CAB+RPV LA? * How does CAB+RPV LA affect HIV stigma, treatment satisfaction, medication adherence and viral suppression? People living with HIV who reside outside of the Omaha, Nebraska metro area and are starting CAB+RPV LA as part of regular medical care for HIV will be invited to participate in this study which invo

Purpose

IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-07-01

Anticipated Date of Last Follow-up
2025-03-13

Estimated Primary Completion Date
2026-04-01

Estimated Completion Date
2026-04-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

55

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CABRPV-Belgium

Identifier

NCT06424964

Link

https://clinicaltrials.gov/study/NCT06424964

Phase

Marketed

Status

Recruiting

Sponsor

Belgian Research on AIDS and HIV Consortium

More details

This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes. Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV Secondary outcomes • Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis

Purpose

Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-01-13

Anticipated Date of Last Follow-up
2025-02-04

Estimated Primary Completion Date
2025-05-01

Estimated Completion Date
2025-07-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

600

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Yale-pharmacist-led-intervention

Identifier

NCT06411223

Link

https://clinicaltrials.gov/study/NCT06411223

Phase

Phase II

Status

Recruiting

Sponsor

Yale University

More details

This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

Purpose

Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-08-01

Anticipated Date of Last Follow-up
2024-08-08

Estimated Primary Completion Date
2025-05-30

Estimated Completion Date
2025-05-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Living with diagnosed HIV * Receiving HIV care-related services from Yale New Haven Health (YNHH) * Currently on oral ART and virally suppressed for at least 6 months (from electronic health review). * Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 6 months (from self-report at screening). * Able to converse comfortably in English or Spanish Exclusion Criteria: * Unable or unwilling to complete informed consent (e.g., have a conservator of person) * Have initiated CAB/RPV oral lead-in prior to enrollment. * Have a contraindication to CAB/RPV LA per label. * Have known or suspected resistance to CAB/RPV * Pregnant or breast-feeding

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

50

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

PANTER

Identifier

NCT06403865

Link

https://clinicaltrials.gov/study/NCT06403865

Phase

Marketed

Status

Not yet recruiting

Sponsor

University Paris 7 - Denis Diderot

More details

Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window. Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment. Population People living with HIV-1

Purpose

Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-05-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-05-03

Estimated Primary Completion Date
2026-04-01

Estimated Completion Date
2026-10-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

280

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CABRPV-Zurich

Identifier

NCT06405464

Link

https://clinicaltrials.gov/study/NCT06405464

Phase

Marketed

Status

Recruiting

Sponsor

University of Zurich

More details

This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.

Purpose

Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-03-01

Anticipated Date of Last Follow-up
2024-05-06

Estimated Primary Completion Date
2025-12-31

Estimated Completion Date
2026-06-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

600

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CHOICE

Identifier

NCT05991622

Link

https://clinicaltrials.gov/study/NCT05991622

Phase

Phase I

Status

Recruiting

Sponsor

Rhode Island Hospital

More details

This is a one-year study that seeks to evaluate perspectives of combined injectable treatment for HIV and OUD. Specifically, with the development of new long-acting medications such as cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine (XR-B) there is a need to better understand factors that influence the delivery and uptake of this type of treatment. Therefore, this study will conduct qualitative (1:1) interviews with 32-45 key stakeholders to assess interest, knowledge, attitudes, barriers, and facilitators to integrated injectable treatment. Our team will utilize qualitative findings to inform clinical strategies to promote uptake and maintenance of long-acting injectable medications for HIV and OUD.

Purpose

Combined Injectable Treatment for HIV and OUD

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-04-01

Anticipated Date of Last Follow-up
2023-08-07

Estimated Primary Completion Date
2024-04-01

Estimated Completion Date
2024-10-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * 18-65 years of age * HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay * Current diagnosis of OUD according to DSM-5 * Able to understand and speak English and to provide written and verbal informed consent * Participants recruited through RIDOC will have an additional requirement of anticipated release from jail/prison within 6 months. Exclusion Criteria: * Currently pregnant, breastfeeding, planning to become pregnant or breastfeed during the study period * Coinfection of Hepatitis B or plans to get treated for Hepatitis C during the study period

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

40

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

IMAdART

Identifier

NCT06159894

Link

https://clinicaltrials.gov/study/NCT06159894

Phase

Marketed

Status

Not provided

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

More details

This is a clinical trial whose main purpose is to evaluate the acceptability of the administration of LA CAB + extended-release RPV as perceived by patients in month 12 in multipurpose day hospital units versus specialized care centers (HIV Units). . Candidates to participate in this study are indicated to receive this medication, so the decision to include the participant in the study will be after the decision to prescribe the drug. These patients will be randomly assigned to one location or another to receive the administration of the medication. Therefore, and after consulting with the AEMPS, it is considered that this is a clinical trial WITHOUT medications. Both the medication and the procedures associated with the follow-up of the participants will follow the usual practice for this

Purpose

Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units".

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-12-18

Anticipated Date of Last Follow-up
2025-06-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-07-15

Actual Primary Completion Date
2025-04-21

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * 1. People living with HIV-1 infection; 2. Aged 18 years or older at the time of signing the informed consent. 3. Virologically suppressed (HIV-1 RNA \<50 copies/ml) on a stable antiretroviral regimen: i) Documented evidence of plasma HIV-1 RNA measurements \<50 copies/mL in the 6 months prior to Screening. 1. Documented evidence of plasma HIV-1 RNA measurements \<50 copies/mL in one determination \> 6 months prior to Screening 2. Documented evidence of plasma HIV-1 RNA measurements \<50 copies/mL in one determination \< 6 months prior to Screening If the last documented evidence of plasma HIV-1 RNA measurements \<50 copies/mL is into the 45 days prior to Screening visit, this determination could replace the screening determination. If all the laboratory results

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

90

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

201584-001

Identifier

NCT05896748

Link

https://clinicaltrials.gov/study/NCT05896748

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).

Purpose

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-11-08

Anticipated Date of Last Follow-up
2024-10-31

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-09-14

Actual Completion Date
2023-09-14

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Capable of giving signed informed consent (FLAIR and Sub-study specific informed consent) * Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 12 months while on the FLAIR study. Any disruptions in dosing during FLAIR must be discussed with the Medical Monitor for a final determination of eligibility into the sub-study. * Plasma HIV-1 RNA \<50 c/mL at Sub-Study Screening. * History of Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination (or booster dosing) is allowed prior to sub study screening and will be allowed during the conduct of the sub-study as long as the vaccine (or boosters) are not administered within 14 days of virologic load (VL) assessments. * HIV-1 infected antiretroviral therapy (ART)-naive men or wo

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

94

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

207966-001

Identifier

NCT05896761

Link

https://clinicaltrials.gov/study/NCT05896761

Phase

Phase III

Status

Completed

Sponsor

ViiV Healthcare

More details

This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M \[A2M\]) study (NCT03299049).

Purpose

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-10-28

Anticipated Date of Last Follow-up
2023-08-22

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-08-23

Actual Completion Date
2022-08-23

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: Sub-study specific Inclusion Criteria: * Capable of giving sub-study specific informed consent. * Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 152 weeks while on the ATLAS2-M study. Any disruptions in dosing during ATLAS2-M must be discussed with the Medical Monitor for a final determination of eligibility into the sub-study. * Plasma HIV-1 RNA \<50 copies/mL at Sub-Study Screening. Inclusion criteria detailed for the ATLAS-2M main study apply to the sub-study: * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin \[hCG\] test) not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: * Pr

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

118

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CABO-LA

Identifier

NCT05835635

Link

https://clinicaltrials.gov/study/NCT05835635

Phase

Not provided

Status

Not yet recruiting

Sponsor

Pontificia Universidad Catolica de Chile

More details

This protocol will assess the level of satisfaction, acceptance of treatment and quality of life of patients with undetectable HIV who voluntarily change from oral to injectable antiretroviral treatment at 72 weeks of follow-up.

Purpose

Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2025-05-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-11-05

Estimated Primary Completion Date
2025-12-01

Estimated Completion Date
2026-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

50

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SCohoLART

Identifier

NCT05663580

Link

https://clinicaltrials.gov/study/NCT05663580

Phase

Not provided

Status

Recruiting

Sponsor

Castagna Antonella

More details

Systematic, continuative collection of clinical and laboratory data on patients followed at lnfectious Diseases Unit of the IRCCS San Raffaele Hospital in Milan, receiving long-acting ART (Phase IV, single-center, prospective, cohort study) PRIMARY ENDOPOINT: Treatment failure over 48 weeks, defined as virological failure (VF) or therapy discontinuation for any reason (TD) SECONDARY ENDPOINTS: Clinical and pharmacological determinants of efficacy, tolerability, toxicity Modifications in risk and incidence of comorbidities Description of drug-resistance in case of VR Efficacy of rescue regimens in case of VF Quality of life and patient's satisfaction

Purpose

Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-07-17

Anticipated Date of Last Follow-up
2025-05-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2027-07-17

Actual Primary Completion Date
2024-07-17

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

1500

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

2179

Identifier

NCT05152953

Link

https://clinicaltrials.gov/study/NCT05152953

Phase

Not provided

Status

Completed

Sponsor

University of California, San Francisco

More details

BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) is poised to revolutionize HIV treatment and prevention. Community pharmacies could serve as another place for people with HIV to get their ART injections. However, pharmacist and healthcare practitioner attitudes towards pharmacist administration of LAI-ART are understudied. Financial and human resources, pharmacist training, or changes in workflow have not been outlined. Little is known about whether patients will accept ART injections given in pharmacies. OBJECTIVE: The purpose of this project is to address the above knowledge gaps. The information generated can assist in the development of tools that can help scale community pharmacy-based delivery of LAI-ART. METHODS: Using a mixed-methods approach to better underst

Purpose

Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-06-08

Anticipated Date of Last Follow-up
2023-11-27

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-11-15

Actual Completion Date
2023-11-15

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Not provided

Enrollment

63

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Kuwa Free! - Live Free!

Identifier

NCT05044962

Link

https://clinicaltrials.gov/study/NCT05044962

Phase

Not provided

Status

Recruiting

Sponsor

University of Alabama at Birmingham

More details

The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators wil

Purpose

Kuwa Free! - Live Free!

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-26

Anticipated Date of Last Follow-up
2025-04-07

Estimated Primary Completion Date
2026-03-31

Estimated Completion Date
2026-03-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults

Genders

• Female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria (PK study): * Female sex, * HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only), * Age 15-24 years at the time of enrollment, * Documented or confirmed viral suppression for HIV (defined as \<40 copies/mL) within 6 months prior to study enrollment, * Have been on the study oral drug for at least 4 weeks for the PK groups #1-4, * Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively, * Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period * Able to consent or assent (with parental consent) for study participation in English or Kiswahili Exclusion Criteria (PK study): * Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inh

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

700

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CHORUS-tracking

Identifier

NCT04863261

Link

https://clinicaltrials.gov/study/NCT04863261

Phase

Not provided

Status

Completed

Sponsor

Epividian

More details

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

Purpose

Cabenuva Injection Tracking in CHORUS

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-10-01

Anticipated Date of Last Follow-up
2025-02-24

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-07-07

Actual Completion Date
2022-07-07

Studied populations

Age Cohort

• Children
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria (patients): * As per label, routine clinical care Inclusion Criteria (clinics): * AIDS Healthcare Foundation (AHF) Clinic * HIV primary care clinic * Minimum of 100 people living with HIV in care with a viral load \<50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

37

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

116181

Identifier

NCT01467531

Link

https://clinicaltrials.gov/study/NCT01467531

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are schedu

Purpose

A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2011-11-01

Anticipated Date of Last Follow-up
2012-10-11

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2012-02-01

Actual Completion Date
2012-02-01

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator feels that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent. * A female subject is

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

28

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

The novel excipient poloxamer 338 (P338) is used in the final G001 Rilpivirine clinical formulation. Following both an in-vitro mammalian chromosome aberration and an Ames test, it was considered to be non-genotoxic with no evidence for mutagenicity. Further P338 fertility, genotoxicity and development studies have been conducted with no negative effects, in addition to a 6-week and 9- month minipig repeat-dose toxicity study. No adverse local or systemic toxicity was reported in the minipigs at 100mg/month (Margin of Exposure:19).

Residual solvents used

No residual solvent used

Formulation patent families

Publications

Bares SH, Scarsi KK. A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. Curr Opin HIV AIDS. 2022 Jan 1;17(1):22-31. doi: https://doi.org/10.1097/COH.0000000000000708. PMID: 34871188; PMCID: PMC8694245.

Purpose of review

Cabotegravir (CAB) and rilpivirine (RPV) is the first long-acting injectable antiretroviral therapy (ART) option approved for virologically suppressed adults with HIV-1. In addition, long-acting CAB is a promising agent for HIV preexposure prophylaxis (PrEP). This review focuses on phase 3 clinical trial results and implementation considerations for these long-acting ART and PrEP strategies.

Recent findings

Long-acting CAB and RPV administered every 4 weeks demonstrated noninferiority to oral ART through week 96 in both the ATLAS and FLAIR studies, whereas ATLAS-2M found similar efficacy through 96 weeks when the long-acting injectable ART was administered every 8 weeks instead of every 4 weeks. For prevention, two phase 3 trials were stopped early due to fewer incident HIV infections in participants receiving long-acting CAB every 8 weeks compared with daily oral tenofovir disoproxil fumarate–emtricitabine for PrEP. The long-acting therapies were well tolerated across all clinical trials.

Summary

Clinical trial results support the use of long-acting CAB for HIV PrEP and long-acting CAB and RPV as a switch strategy for adults with HIV-1 who are first virologically suppressed with oral ART. Implementation challenges persist, and data are urgently needed in populations who may benefit most from long-acting therapy, including adolescents, pregnant individuals, and those with barriers to medication adherence.

Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Implement Sci. 2009;4:50. Published 2009 Aug 7. doi:10.1186/1748-5908-4-50

Background: Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts.

Methods: We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts.

Results: The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct.

Conclusion: The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.

Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Proctor E, Silmere H, Raghavan R, et al. Adm Policy Ment Health. 2011;38(2):65-76. doi:10.1007/s10488-010-0319-7

An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of "implementation outcomes" distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working "taxonomy" of eight conceptually distinct implementation outcomes-acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability-along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.

Chloe Orkin, Rosalie Hayes, Joanne Haviland, Yuk Lam Wong, Kyle Ring, Vanessa Apea, Bakita Kasadha, Emily Clarke, Ruth Byrne, Julie Fox, Tristan J Barber, Amanda Clarke, Sara Paparini, For the ILANA study Group (Sadna Ullah, Nishat Halim, Chikondi Mwendera, James Hand), Perspectives of People With HIV on Implementing Long-acting Cabotegravir Plus Rilpivirine in Clinics and Community Settings in the United Kingdom: Results From the Antisexist, Antiracist, Antiageist Implementing Long-acting Novel Antiretrovirals Study, Clinical Infectious Diseases, Volume 80, Issue 5, 15 May 2025, Pages 1103–1113, https://doi.org/10.1093/cid/ciae523

Introduction

The equity-focused Implementing Long-Acting Novel Antiretrovirals study evaluated feasibility, acceptability, appropriateness of delivering on-label 2-monthly cabotegravir and rilpivirine (CAB + RPV) injections for human immunodeficiency virus (HIV)-1 therapy in clinics and community settings.

Methods

The study, which mandated inclusive recruitment, was conducted May–December 2022 at 6 UK sites. Injections were delivered in clinic (month [M] 1–6) and in clinic or community setting according to patient choice (M6–12). Surveys were completed at baseline, M4, and M12 using validated measures for feasibility (FIM), acceptability (AIM), and appropriateness (IAM). Primary endpoint: proportion of participants agreeing that the injection and community setting were feasible (FIM ≥4) at M12. Fourteen participants completed interviews at baseline and M12.

Results

Community settings offered by sites included: home visits (n = 3), HIV support organizations (n = 2), and community clinic (n = 1). Of 114 participants, 54% were female, 70% racially minoritized, and 40% aged ≥50 years. A total of 27/114 chose to receive injections in community settings. FIM/AIM/IAM scores at M12 were high for the injection (79.0–87.4%) and lower for the community setting (44.2–47.4%) overall. Subgroup analyses indicated differences in scores by gender and ethnicity. Among those who attended the community, FIM/AIM/IAM scores for the community setting at M12 were high (73.1–80.8%). Concerns about stigma, inconvenience, and losing access to trusted clinicians negatively influenced perceptions of receiving injections at community settings, amongst other factors.

Conclusions

CAB + RPV injections were considered highly feasible, acceptable, and appropriate; however, few chose community delivery. Those that chose community delivery found it highly acceptable and feasible. Further exploration of CAB + RPV delivery in alternative community sites not offered (eg, primary care, pharmacies) is warranted.

John M, Williams L, Nolan G, Bonnett M, Castley A, Nolan D. Real-world use of long-acting cabotegravir and rilpivirine: 12-month results of the inJectable Antiretroviral therapy feasiBility Study (JABS). HIV Med. 2024; 25(8): 935-945. doi:10.1111/hiv.13647

Objectives

The inJectable Antiretroviral feasiBility Study (JABS) aimed to evaluate the implementation of long-acting regimens in a ‘real world’ Australian setting, with inclusion of participants with complex medical needs, social vulnerability and/or historical non-adherence.

Methods

JABS was a 12-month, single-centre, single-arm, open-label phase IV study of long-acting cabotegravir 600 mg plus rilpivirine 900 mg administered intramuscularly every 2 months to adults with treated HIV-1 infection. The primary endpoint was the proportion of attendances and administration of injections within a 14-day dosing window over 12 months, out of the total prescribed doses. Secondary endpoints included proportions of missed appointments, use of oral bridging, discontinuations, virological failures, adverse events and participant-reported outcomes. A multidisciplinary adherence programme embedded in the clinical service known as REACH provided support to JABS participants.

Results

Of 60 participants enrolled by May 2022, 60% had one or more complexity or vulnerability factors identified, including absence of social supports (50%), mental health issues, alcohol or drug use (30%) and financial hardship or instability (13%), among others. Twenty-seven per cent of participants had historical non-adherence to antiretroviral therapy. Out of 395 prescribed doses, 97.2% of injections were administered within correct dosing windows at clinic visits. Two courses of short-term oral bridging were required. The rate of injection site reactions was 29%, the majority being grade 1–2. There were no virological failures, no serious adverse events and only one injection-related study discontinuation. High baseline treatment satisfaction and acceptability of injections increased by month 12. Those with vulnerability factors had similar adherence to injections as those without such factors. Ninety-eight per cent of the participants who completed 12 months on the study have maintained long-acting therapy, virological suppression and retention in care.

Conclusions

Long-acting cabotegravir plus rilpivirine was associated with very high adherence, maintenance of virological suppression, safety and treatment satisfaction in a diverse Australian clinic population, comparable to results of phase III randomized clinical trials. Individuals with vulnerability factors can achieve adherence to injections with individualized support. Long-acting therapies in this group can increase the subsequent engagement in clinical care.

Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomised, multicentre, open-label, non-inferiority trial. Kityo Cissy, Mugerwa Henry et al. The Lancet Infectious Diseases, Volume 24, Issue 10, 1083 - 1092

Background

Long-acting injectable cabotegravir and rilpivirine is licensed for individualised treatment of HIV-1 infection in resource-rich settings. Additional evidence is required to support use in African treatment programmes where demographic factors, viral subtypes, previous treatment, and delivery and monitoring approaches differ. The aim of this study was to determine whether switching to long-acting therapy with injections every 8 weeks is non-inferior to daily oral therapy in Africa.

Methods

CARES is a randomised, open-label, non-inferiority trial being conducted at eight sites in Uganda, Kenya, and South Africa. Participants with HIV viral load below 50 copies per mL on oral antiretroviral therapy and no history of virological failure were randomly assigned (1:1; web-based, permuted blocks) to receive cabotegravir (600 mg) and rilpivirine (900 mg) by intramuscular injection every 8 weeks, or to continue oral therapy. Viral load was monitored every 24 weeks. The primary outcome was week 48 viral load below 50 copies per mL, assessed with the Food and Drug Administration snapshot algorithm (non-inferiority margin 10 percentage points) in the intention-to-treat exposed population. This trial is registered with the Pan African Clinical Trials Registry (202104874490818) and is ongoing up to 96 weeks.

Findings

Between Sept 1, 2021, and Aug 31, 2022, we enrolled 512 participants (295 [58%] female; 380 [74%] previous non-nucleoside reverse transcriptase inhibitor exposure). Week 48 viral load was below 50 copies per mL in 246 (96%) of 255 participants in the long-acting therapy group and 250 (97%) of 257 in the oral therapy group (difference –0·8 percentage points; 95% CI –3·7 to 2·3), demonstrating non-inferiority (confirmed in per-protocol analysis). Two participants had virological failure in the long-acting therapy group, both with drug resistance; none had virological failure in the oral therapy group. Adverse events of grade 3 or greater severity occurred in 24 (9%) participants on long-acting therapy and ten (4%) on oral therapy; one participant discontinued long-acting therapy (for injection-site reaction).

Interpretation

Long-acting therapy had non-inferior efficacy compared with oral therapy, with a good safety profile, and can be considered for African treatment programmes.

Oka S, Holohan V, Shirasaka T, et al. Asian participants' experience in phase 3/3b studies of long-acting cabotegravir and rilpivirine: Efficacy, safety, pharmacokinetic, and virological outcomes through week 96. HIV Med. 2024;25(3):381‐390. doi:10.1111/hiv.13588

Objectives:

Cabotegravir + rilpivirine (CAB + RPV) dosed monthly or every 2 months is the first complete long-acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV-1 virological suppression. This post hoc analysis summarizes outcomes for Asian participants through week 96.

Methods:

Data from Asian participants naive to CAB + RPV randomized to receive dosing every 4 weeks (Q4W) or every 8 weeks (Q8W) in the FLAIR (NCT02938520) and ATLAS-2M (NCT03299049) phase 3/3b studies were pooled. The proportion of participants with plasma HIV-1 RNA ≥50 and <50 copies/mL (per FDA Snapshot algorithm), incidence of confirmed virological failure (CVF; two consecutive HIV-1 RNA ≥200 copies/mL), pharmacokinetics, safety, and tolerability through week 96 were assessed.

Results:

Overall, 41 Asian participants received CAB + RPV (Q8W, n = 17; Q4W, n = 24). At week 96, 83% (n = 34/41) of participants maintained HIV-1 RNA <50 copies/mL, none had HIV-1 RNA ≥50 copies/mL, and 17% (n = 7/41) had no virological data. No Asian participant met the CVF criterion. Drug-related adverse events occurred in 44% (n = 18/41) of participants; none were Grade ≥3. All injection site reactions were Grade 1 or 2; median duration was 2 days and most resolved within 7 days (90%, n = 390/435). CAB and RPV trough concentrations remained well above their respective proteinadjusted 90% inhibitory concentrations (CAB, 0.166 μg/mL; RPV, 12 ng/mL) through week 96.

Dima Dandachi, Cindy Garris, David Richardson, Gary Sinclair, Doug Cunningham, William Valenti, Bintu Sherif, Maria Reynolds, Kate Nelson, Deanna Merrill, Cathy Schubert, Kaitlin Nguyen, Ana Puga, Paula Teichner, Laurie Zografos, Clinical Outcomes and Perspectives of People With Human Immunodeficiency Virus Type 1 Twelve Months After Initiation of Long-acting Cabotegravir and Rilpivirine in an Observational Real-world US Study (BEYOND), Open Forum Infectious Diseases, Volume 12, Issue 5, May 2025, ofaf220, https://doi.org/10.1093/ofid/ofaf220

Background

Long-acting cabotegravir plus rilpivirine (CAB + RPV LA) administered monthly or every 2 months is recommended by treatment guidelines for maintenance of virologic suppression in people with human immunodeficiency virus type 1 (HIV-1). In clinical trials, CAB + RPV LA demonstrated noninferiority versus United States (US) Food and Drug Administration–approved daily oral therapy, and outcomes in real-world settings can supplement these results. We present month 12 results of BEYOND.

Methods

BEYOND is an ongoing, 2-year, multicenter, prospective, observational real-world study of adults initiating CAB + RPV LA in the US. Key outcomes included reasons for initiating, virologic outcomes, adherence, and patient-reported outcomes related to treatment satisfaction and treatment challenges at baseline and month 12.

Results

In total, 308 participants (median age, 45 years; 83% identified as male; 39% identified as Black) initiated CAB + RPV LA most commonly because of treatment fatigue, adherence anxiety with daily oral therapy, and/or convenience. Of participants with baseline viral load data, 97% (194/200) had a viral load <50 copies/mL for their most recent test reported at month 12. Mean treatment satisfaction scores increased significantly from baseline to month 12 and 97% (223/229) of participants preferred LA versus oral treatment at month 12. Proportions of participants reporting “always” or “often” experiencing challenges related to HIV-1 treatment (fear of disclosure, adherence anxiety, reminder of HIV-1 status, and feeling stigmatized) decreased from baseline to month 12.

Conclusions

Month 12 results from the real-world BEYOND study support the effectiveness of CAB + RPV LA for maintenance of virologic suppression and as a preferred treatment option for people with HIV-1.

Ford SL, Felizarta F, Han K, et al. Thigh Injections of Cabotegravir + Rilpivirine in Virally Suppressed Adults With Human Immunodeficiency Virus Type 1: A Substudy of the Phase 3b ATLAS-2M Study. Clin Infect Dis. Published online January 29, 2025. doi:10.1093/cid/ciae620

Background: Cabotegravir + rilpivirine (CAB + RPV) administered via intramuscular gluteal injections is the first complete long-acting regimen for maintaining human immunodeficiency virus type 1 (HIV-1) virologic suppression. We present substudy results on short-term repeat intramuscular CAB + RPV long-acting thigh injections in participants with ≥3 years of experience with gluteal administration during the ATLAS-2M study.

Methods: Substudy phases included screening, thigh injection (day 1-week 16), and return to gluteal injection (week 16-week 24). The injection schedule was unchanged from the main study. Outcomes included pharmacokinetics, safety, tolerability, efficacy, and patient-reported outcomes. Pharmacokinetic parameters were determined using noncompartmental analysis and mixed-effects modeling. Population pharmacokinetic simulations were performed.

Results: There were 118 participants. In the arm that received injections every 2 months (Q2M), first CAB thigh injection including area under the concentration-time curve and maximum observed concentration (Cmax) and first RPV thigh injection Cmax and all last RPV thigh injection parameters were statistically higher vs gluteal injections (paired comparison). No significant differences occurred with once-monthly (QM) dosing. No participants had HIV-1 RNA ≥50 copies/mL after thigh injections. Overall, 4%-7% of injection site reactions (ISRs) were grade 3. Five participants withdrew due to an ISR or injection intolerability. Overall, 30% preferred thigh vs gluteal injections. Simulations demonstrated the potential for chronic/continuous QM or ≤2 consecutive Q2M thigh injections.

Conclusions: These data demonstrate the potential use of chronic/continuous QM and rotational/short-term QM or Q2M (≤4 months of continuous dosing), CAB + RPV long-acting intramuscular thigh administration for HIV-1 treatment.