Cabotegravir 2-monthly

Drug information

Delivery device(s)

No delivery device

Scale-up prospects

Compound is commercially manufactured by the innovator and three generic manufacturers have received a licence through the medicines patent pool to manufacture generic versions by 2026/2027.

Tentative equipment list for manufacturing

Conventional wet-bead milling (ball mill), depyrogenated glass vials.

Manufacturing

Cabotegravir is subject to a gamma-irradiation pre-sterilization step prior to a conventional wet-bead milling manufacturing procedure. The Cabotegravir milling process is initiated alongside pharmaceutical excipients (polyethylene glycol 3350, water for injection, polysorbate 20 and mannitol) for an overall 200nm drug particle size. Sterilized de-pyrogenated glass vials are used to store the finished drug nanosuspension, before an additional gamma irradiation (25kGy) step to ensure aseptic packaging conditions.

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) to determine drug particle size, Mettler TGA/DSC 1 instrument for thermal analysis, HPLC to evaluate drug content, impurities and dissolution, HPLC UV-Vis Detector for drug identification.

ECLAIR

Identifier

NCT02076178

Link

https://clinicaltrials.gov/study/NCT02076178

Phase

Phase II

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the safety, tolerability and acceptability of long acting injections of the HIV integrase inhibitor, GSK1265744, in HIV-uninfected men.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2014-03-27

Anticipated Date of Last Follow-up
2017-12-13

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2015-05-15

Actual Completion Date
2016-02-23

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male
• Transgender male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Non-reactive HIV test at screening or enrollment. - Males 18 to 65 years old at the time of signing the informed consent. - At risk of acquiring HIV, defined as having at least one casual sex partner in the past 24 months. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening. - If participating in sexual activity with a female of child-bearing potential, men must agree to use condoms. Female partner must use contraception. - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. - Willing to undergo all required study procedures.

Health status

Study type

Interventional (clinical trial)

Enrollment

127

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HPTN 077

Identifier

NCT02178800

Link

https://clinicaltrials.gov/study/NCT02178800

Phase

Phase II

Status

Completed

Sponsor

National Institute of Allergy and Infectious Diseases

More details

Not provided

Purpose

Evaluate the safety, tolerability, and pharmacokinetics of an investigational, injectable HIV medicine (GSK1265744) in HIV-uninfected adults.

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
2015-02-01

Anticipated Date of Last Follow-up
2021-10-14

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2017-04-05

Actual Completion Date
2018-07-13

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

Men and women, 18 to 65 years old at the time of screening, who are willing to provide informed consent for the study. Participants are required to be in general good health, as confirmed by laboratory investigation, with no medical condition(s) that would interfere with the conduct of the study.

Health status

Study type

Interventional (clinical trial)

Enrollment

199

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HPTN 083

Identifier

NCT02720094

Link

https://clinicaltrials.gov/study/NCT02720094

Phase

Phase II/III

Status

Not provided

Sponsor

National Institute of Allergy and Infectious Diseases

More details

Not provided

Purpose

Evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men.

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
2016-12-01

Anticipated Date of Last Follow-up
2024-11-07

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-04-30

Actual Primary Completion Date
2020-05-14

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male
• Transgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

HIV negative cis-gender men and transgender women (18 years or older at the time of screening [assigned male at birth]) who have sex with men and at high risk of HIV infection.

Health status

Study type

Interventional (clinical trial)

Enrollment

4570

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

HPTN 084

Identifier

NCT03164564

Link

https://clinicaltrials.gov/study/NCT03164564

Phase

Phase III

Status

Not provided

Sponsor

National Institute of Allergy and Infectious Diseases

More details

Not provided

Purpose

Evaluate the safety and efficacy of CAB LA compared to daily oral tenofovir disoproxil fumarate/emtricitabine for PrEP in HIV-uninfected women.

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
2017-11-07

Anticipated Date of Last Follow-up
2024-09-26

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2024-11-30

Actual Primary Completion Date
2020-11-05

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Born female and 18-45 years of age at the time of screening. Must have documented evidence of surgical sterilization, OR documented evidence of no uterus (e.g., hysterectomy), OR must agree to use a reliable form of long acting contraception, during the trial and for 52 weeks after stopping the long acting injectable, or 30 days after stopping oral study product

Health status

Study type

Interventional (clinical trial)

Enrollment

3224

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

EBONI

Identifier

NCT05514509

Link

https://clinicaltrials.gov/study/NCT05514509

Phase

Marketed

Status

Not provided

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate implementation strategies for the delivery of CAB for HIV PrEP across clinical settings for adult (≥18 Years) black cis-and transgender women without HIV infection living in the United States

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-10-28

Anticipated Date of Last Follow-up
2025-06-17

Estimated Primary Completion Date
2025-08-29

Estimated Completion Date
2025-08-29

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender female
• Transgender female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion criteria: - Participant must be ≥18 years of age, at the time of signing the informed consent. - HIV negative at screening. Type of HIV-1 test is per standard of care. - No prior history of receiving oral CAB or CAB LA injections. - PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study. - Female at birth or self-identified Transgender Female. - Self-identified as African American/Black. - Capable of giving signed informed consent.

Health status

Study type

Interventional (clinical trial)

Enrollment

156

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

PrEP

Key resources

PILLAR

Identifier

NCT05374525

Link

https://clinicaltrials.gov/study/NCT05374525

Phase

Marketed

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate implementation strategies for the delivery of cabotegravir PrEP for HIV uninfected MSM and transgender men ≥ 18 in the United States.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-05-18

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

Estimated Primary Completion Date
2024-09-06

Estimated Completion Date
2024-09-06

Actual Primary Completion Date
2024-08-08

Actual Completion Date
2024-08-08

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male
• Transgender male

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

201

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

PrEP

Key resources

ImPrEP

Identifier

NCT05515770

Link

https://clinicaltrials.gov/study/NCT05515770

Phase

Phase III

Status

Recruiting

Sponsor

Evandro Chagas National Institute of Infectious Disease

More details

Not provided

Purpose

Assess the safety and effectiveness of open label CAB LA PrEP when offered at public health facilities to cisgender men and transgender or gender non-binary individuals who have sex with men.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2022-09-20

Actual Start Date
2022-09-20

Anticipated Date of Last Follow-up
2024-10-03

Estimated Primary Completion Date
2025-10-01

Estimated Completion Date
2026-02-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Cisgender male
• Transgender female
• Transgender male
• Gender non-binary

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Cisgender men, non-binary (assigned as male at birth), transgender women and transgender men who are seeking a PrEP study clinic and age 18-30 years. Study participants must report having anal sex in the last six months with a person assigned male gender at birth.

Health status

Study type

Interventional (clinical trial)

Enrollment

1200

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Methods include qualitative (focus group discussion and in-depth interviews) and quantitative (service statistics, laboratory tests, surveys) approaches. The incidence of HIV in the CAB LA study cohort will be evaluated against a similar cohort receiving oral PrEP. Interrupted time series analysis will be utilised to assess the effectiveness of the mHealth intervention.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

SEARCH SAPPHIRE DCP Extension

Identifier

NCT05549726

Link

https://clinicaltrials.gov/study/NCT05549726

Phase

Marketed

Status

Completed

Sponsor

University of California, San Francisco

More details

Not provided

Purpose

Determine whether adding the option of CAB-LA as HIV PrEP increases prevention coverage compared to the standard-of-care in three ongoing randomized trials of dynamic choice in rural Uganda and Kenya.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-01-02

Anticipated Date of Last Follow-up
2025-01-30

Estimated Primary Completion Date
Not provided

Estimated Completion Date
2025-01-01

Actual Primary Completion Date
2023-12-18

Actual Completion Date
2025-01-30

Studied populations

Age Cohort

• Adolescents
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Participants must be enrolled in a SEARCH Sapphire Dynamic prevention study (NCT04810650).

Health status

Study type

Interventional (clinical trial)

Enrollment

984

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

CAB-LA will be offered to participants that are initially assigned to the Dynamic Choice Prevention delivery model.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

NCT02478463

Identifier

NCT02478463

Link

https://clinicaltrials.gov/study/NCT02478463

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Determine the PK concentrations of CAB following LA administration in relevant tissues and fluids of healthy men and women following a single 600 mg IM dose.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-02-27

Anticipated Date of Last Follow-up
2020-06-02

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2019-07-25

Actual Completion Date
2019-07-25

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Between 18 and 55 years of age inclusive, at the time of signing the informed consent. - Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive). - Male or female. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. - All subjects participating in the study must be counselled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission.

Health status

Study type

Interventional (clinical trial)

Enrollment

19

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

PrEP

Key resources

NCT03422172

Identifier

NCT03422172

Link

https://clinicaltrials.gov/study/NCT03422172

Phase

Phase I

Status

Completed

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected Chinese male subjects at low risk for HIV acquisition.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2018-04-10

Anticipated Date of Last Follow-up
2021-05-12

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2020-04-20

Actual Completion Date
2020-04-20

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: - Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed consent. - Subjects are male at birth. - Subjects who have non-reactive point of care (POC) HIV test and undetectable HIV-1 ribose nucleic acid (RNA) at screening. - At risk of acquiring HIV, defined as having at least one casual male or female sex partner in the past 24 months. - Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening. - Capable of giving written informed consent. - Agree to appropriate use of contraceptive measures during heterosexual intercourse. - Willing to undergo all required study procedures.

Health status

Study type

Interventional (clinical trial)

Enrollment

48

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Eligible subjects will receive oral doses of CAB for 4 weeks followed by IM dosing with CAB LA at Week 5, Week 9, Week 17, Week 25 and Week 33.

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

PALISADE

Identifier

NCT06134362

Link

https://clinicaltrials.gov/study/NCT06134362

Phase

Phase III

Status

Recruiting

Sponsor

ViiV Healthcare

More details

Not provided

Purpose

Long-term follow-up and evaluation of CAB LA for participants in the HPTN 083 and HPTN 084 CAB PrEP studies who are at risk of HIV acquisition.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-04-01

Actual Start Date
2024-05-24

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

Estimated Primary Completion Date
2028-06-26

Estimated Completion Date
2028-06-26

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adolescents
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Yes

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Participants must be currently enrolled and ongoing in one of the following studies: (1) HPTN 083 (2) HPTN 084 (3) HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study.

Health status

Study type

Interventional (clinical trial)

Enrollment

3500

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

PrEP

Key resources

TSHIRELETSO

Identifier

NCT05986084

Link

https://clinicaltrials.gov/study/NCT05986084

Phase

Marketed

Status

Recruiting

Sponsor

Beth Israel Deaconess Medical Center

More details

Not provided

Purpose

aluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in postpartum people who are breastfeeding.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-30

Anticipated Date of Last Follow-up
2025-04-23

Estimated Primary Completion Date
2027-08-31

Estimated Completion Date
2027-08-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Cisgender female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Yes

Accepts healthy individuals
No

Comments about the studied populations

Participants are postpartum (< 14 days after delivery) mothers who are aged 18-30 with less than a total of three prior pregnancies. Participants should plan to stay and receive postpartum and paediatric care in the Gaborone or Molepolole region of Botswana for at least 24 months.

Health status

Study type

Interventional (clinical trial)

Enrollment

500

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

PrEP

Key resources

AXIS

Identifier

NCT06138600

Link

https://clinicaltrials.gov/study/NCT06138600

Phase

Phase III

Status

Not provided

Sponsor

University of Witwatersrand, South Africa

More details

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC\[3TC\]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum

Purpose

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-01

Anticipated Date of Last Follow-up
2024-06-19

Estimated Primary Completion Date
2025-10-31

Estimated Completion Date
2026-01-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion criteria: - Each participant must meet all of the following criteria to be enrolled in this study: 1. Adult male or female (≥18 and ≤ 35 years old) 2. Is self-reported sexually active 3. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1) 4. Body weight ≥ 35 kilograms. 5. Creatinine clearance ≥ 60 mL/min. 6. Willingness to sign informed consent.

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

200

Allocation

Non-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

PrEP

Key resources

PEACH

Identifier

NCT05072093

Link

https://clinicaltrials.gov/study/NCT05072093

Phase

Marketed

Status

Completed

Sponsor

Emory University

More details

The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-

Purpose

Parrying the Pitfalls of PrEP: Project PEACH

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-11-20

Anticipated Date of Last Follow-up
2025-05-29

Estimated Primary Completion Date
2025-02-01

Estimated Completion Date
2025-02-01

Actual Primary Completion Date
2025-03-31

Actual Completion Date
2025-03-31

Studied populations

Age Cohort

• Adults

Genders

• Male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Male at birth * Self-identify as Cisgender Male * Ages 18-45 years * ≥1 male anal sex partner in the 12 months before the baseline interview * Live in the Atlanta MSA * Owns cell phone with data service * Willing to download a health-related app to their cell phone as part of the research study * Able to provide ≥ 2 means of contact * Not currently enrolled in another HIV prevention clinical trial * Confirmed HIV-negative at baseline visit Exclusion Criteria: * Female at birth * Do not self-identify as Cisgender Male * Individuals \< 18 years of age or \> 45 years of age * HIV positive status * No male anal sex partner in the 12 months before the baseline interview * Does not own mobile phone with data service * Not willing to download a health-related app to their

Health status

Study type

Interventional (clinical trial)

Enrollment

240

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

PrEP

Key resources

MOBILEMEN

Identifier

NCT06133686

Link

https://clinicaltrials.gov/study/NCT06133686

Phase

Phase III

Status

Not yet recruiting

Sponsor

MRC/UVRI and LSHTM Uganda Research Unit

More details

Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried out in 400 HIV negative men aged 18+ years in South Africa and Uganda. Men will be randomized 1:1 to either Group A: oral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) PrEP (event-driven or daily) or Group B: Long-acting injectable cabotegravir (CAB-LA) over 9-months. After 9-months participants from both groups will be offered choice of PrEP (oral TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Various strategies to support Pr

Purpose

Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-04-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2023-11-13

Estimated Primary Completion Date
2025-12-31

Estimated Completion Date
2027-04-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. Able and willing to provide informed consent 2. Aged 18 years and above on the day of screening 3. Willing to have a HIV test and receive the test results 4. Male at birth 5. In the past 6-months has travelled for work or to find work and spent at least one night away from home for work related purposes. 6. Available for follow up for the duration of the study Exclusion Criteria: 1. Known HIV infection 2. Confirmed HIV-positive test result, indeterminate HIV test result, and/or signs and symptoms of an acute HIV infection 3. Body weight less than 35Kg at baseline 4. Allergy to any of the study products 5. Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g

Health status

Study type

Interventional (clinical trial)

Enrollment

400

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

PrEP

Key resources

PathToScale

Identifier

NCT06319105

Link

https://clinicaltrials.gov/study/NCT06319105

Phase

Marketed

Status

Recruiting

Sponsor

Georgetown University

More details

The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels.

Purpose

PathToScale: An Implementation Evaluation

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-03-26

Anticipated Date of Last Follow-up
2024-03-28

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

Observational studies (incl. patient registries)

Enrollment

9900

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

PrEP

Key resources

IDCaPP

Identifier

NCT05867212

Link

https://clinicaltrials.gov/study/NCT05867212

Phase

Marketed

Status

Not yet recruiting

Sponsor

Kelley-Ross & Associates, Inc.

More details

The goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for PrEP program in a community pharmacy setting. The main question it aims to answer are: * Is the program feasible and acceptable at the end of 1 year of operations? * What are the facilitators and barriers of the program? Participants who want to start the FDA approved cabotegravir long acting injectable medication for PrEP will have the option participating in surveys and a review of their electronic health records. Medication will be administered based on FDA approved labeling guidelines and their PrEP care will be part of standard of care per CDC. Pharmacists who want to provide the service to their patients will

Purpose

Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2023-06-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2023-05-16

Estimated Primary Completion Date
2025-11-30

Estimated Completion Date
2025-11-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Yes

Accepts lactating individuals
Yes

Accepts healthy individuals
Yes

Comments about the studied populations

Not provided

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

50

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

PrEP

Key resources

HIPCY

Identifier

NCT06474364

Link

https://clinicaltrials.gov/study/NCT06474364

Phase

Marketed

Status

Not yet recruiting

Sponsor

MU-JHU CARE

More details

Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. The investigators propose to evaluate novel evidence-based HIV prevention and care interventions (including Cabotegravir LongActing (CABLA) to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda. The results will provide important evidence to inform Uganda and other regional countries' policy on integrated HIV prevention, care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections (STIs) in order to reach the UNAIDS 95-95-95 targets and HIV epidemic

Purpose

HIV Prevention and Care Interventions for Youth in Uganda

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-07-15

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-06-19

Estimated Primary Completion Date
2028-08-31

Estimated Completion Date
2028-08-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adolescents
• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Adolescents and young adults with increased likelihood of HIV acquisition * AYA 15 to 24 years of age * Classified as high risk using our screening tool. * Documented HIV un-infected as per the national HIV testing algorithm. * Willing to use PrEP * Willing to provide written informed consent. * No plans to relocate permanently in the next 6 months * No suspicion of acute HIV infection: * Hepatitis B virus surface antigen (HBsAg)-negative and accepts HB vaccination * Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results. * HIV-uninfected, based on HIV test results obtained at screening and enrolment visit and just prior to randomization. All HIV test res

Health status

Study type

Interventional (clinical trial)

Enrollment

600

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

PrEP

Key resources

CATALYST

Identifier

NCT05937698

Link

https://clinicaltrials.gov/study/NCT05937698

Phase

Marketed

Status

Terminated

Sponsor

FHI 360

More details

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

Purpose

The CATALYST Study

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-05-30

Anticipated Date of Last Follow-up
2025-03-12

Estimated Primary Completion Date
2025-06-30

Estimated Completion Date
2025-06-30

Actual Primary Completion Date
2025-01-27

Actual Completion Date
2025-01-27

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

Observational studies (incl. patient registries)

Enrollment

6069

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

PrEP

Key resources

LAPIS

Identifier

NCT06250504

Link

https://clinicaltrials.gov/study/NCT06250504

Phase

Phase III

Status

Recruiting

Sponsor

Africa Health Research Institute

More details

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa. Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and r

Purpose

Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-02-27

Anticipated Date of Last Follow-up
2024-04-16

Estimated Primary Completion Date
2025-07-01

Estimated Completion Date
2026-03-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Children
• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: All young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH/HIV service Documented HIV negative test Suitable for PrEP and/or already on PrEP Weight \> 35 kg Understand the required dosing schedule and HIV testing. Aware that details can be shared with a peer navigator to support their follow-up If pregnant or breast feeding and/or planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast feeding for CAB LA has not been established and oral daily PrEP is a safe alternative. Exclusion Criteria: History or presence of allergy to the study drugs or their components Inv

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

2000

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

PrEP

Key resources

TIARAS-CAB-WWID

Identifier

NCT05799339

Link

https://clinicaltrials.gov/study/NCT05799339

Phase

Marketed

Status

Recruiting

Sponsor

Alexis Roth

More details

The goal of this study is to elicit information crucial for designing strategies to support engagement in cabotegravir, a long-acting injectable form of pre-exposure prophylaxis (PrEP) to reduce HIV risk among women who inject drugs (WWID), a population with high unmet need that has been understudied in all phases of PrEP research. The main questions this study aims to answer are: 1. How do WWID perceive long-acting injectable cabotegravir (CAB-LA) as a HIV prevention tool? 2. If and how their decisions to initiate CAB-LA as PrEP are informed by their experiences with other long-acting medications, experience with daily oral medications, and their personal circumstance (e.g., like housing or addition severity)? 3. Do PrEP outcomes (e.g., adherence) and engagement in care over time differ

Purpose

Optimizing CAB-LA as PrEP for Women Who Inject Drugs

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-01-13

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

Estimated Primary Completion Date
2025-12-30

Estimated Completion Date
2025-12-30

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• Female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Women who inject drugs

Health status

Study type

Observational studies (incl. patient registries)

Enrollment

144

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

PrEP

Key resources

AXIS

Identifier

NCT06138600

Link

https://clinicaltrials.gov/study/NCT06138600

Phase

Phase III

Status

Not provided

Sponsor

University of Witwatersrand, South Africa

More details

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC\[3TC\]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum

Purpose

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-01

Anticipated Date of Last Follow-up
2024-06-19

Estimated Primary Completion Date
2025-10-31

Estimated Completion Date
2026-01-31

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

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: - Each participant must meet all of the following criteria to be enrolled in this study: 1. Adult male or female (≥18 and ≤ 35 years old) 2. Is self-reported sexually active 3. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1) 4. Body weight ≥ 35 kilograms. 5. Creatinine clearance ≥ 60 mL/min. 6. Willingness to sign informed consent. Exclusion Criteria: - Participants meeting the following criteria will be excluded from participating in the study: 1. Symptoms of HIV seroconversion (see Table 1). 2. Pregnant (participant must have a negative beta human chorionic gonadotrophin (b-hCG) urine test at screening) or lactating women, or women intending to become pregnant or breastfeed during the study. 3. Is in good health, with

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

200

Allocation

Not provided

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

PrEP

Key resources

223616

Identifier

NCT06970223

Link

https://clinicaltrials.gov/study/NCT06970223

Phase

Phase I

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.

Purpose

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

Interventions

Not provided

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-04-22

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

Estimated Primary Completion Date
2025-07-30

Estimated Completion Date
2026-07-07

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: Participants are eligible to be included in the study only if all the following criteria apply: 1. At the time of obtaining informed consent, 18 years of age. 2. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive). 3. Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring. 4. A participant with a significant clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

60

Allocation

Randomized

Intervention model

Cross-over 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

HPTN 084-01

Identifier

NCT04824131

Link

https://clinicaltrials.gov/study/NCT04824131

Phase

Phase II

Status

Completed

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

Purpose

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-11-04

Anticipated Date of Last Follow-up
2024-11-07

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2023-01-10

Actual Completion Date
2023-01-10

Studied populations

Age Cohort

• Children

Genders

• Female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Assigned female at birth * At enrollment, below 18 years of age * At enrollment, body weight ≥ 35 kg (77 lbs.) * Willing and able to provide informed assent/consent for the study and/or able to obtain written parental/guardian informed consent * Self-reported sexual activity with a male (oral, anal or vaginal) in the past 12 months * Willing and able to undergo all study procedures * In general, good health, as evidenced by the following laboratory values: * Non-reactive / negative HIV test results\*\*, * Absolute neutrophil count \> 799 cells/mm3, * Platelet count ≥ 100,000/mm3, * Hemoglobin ≥ 11g/dL, * Calculated creatinine clearance ≥ 60 mL/minute using the modified Schwartz equation, * Alanine aminotransferase (ALT) \< 2.0 times the upper limit of no

Health status

Study type

Interventional (clinical trial)

Enrollment

55

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

Not provided

Use case

PrEP

Key resources

PrEPared to Choose (PtC)

Identifier

NCT06807736

Link

https://clinicaltrials.gov/study/NCT06807736

Phase

Marketed

Status

Recruiting

Sponsor

Desmond Tutu HIV Foundation

More details

The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation. Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet th

Purpose

PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offere

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-02-13

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

Estimated Primary Completion Date
2025-12-31

Estimated Completion Date
2026-03-31

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

1800

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

PrEP

Key resources

CABOPrEP

Identifier

NCT06273943

Link

https://clinicaltrials.gov/study/NCT06273943

Phase

Phase III

Status

Not yet recruiting

Sponsor

ANRS, Emerging Infectious Diseases

More details

The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors.

Purpose

Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2024-04-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2024-02-21

Estimated Primary Completion Date
2025-10-30

Estimated Completion Date
2026-10-30

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. * Cisgender men who have sex with men. * Have taken oral TDF/FTC based PrEP during the past 6 months, either daily or on-demand, with a documented PrEP prescription. * Agreeing to be contacted personally by telephone (call, SMS) or e-mail. * Person affiliated with or a beneficiary of a social security scheme (article L1121-11 of the Public Health Code). * Informed and written consent, signed by the person and the investigator on the day of inclusion, at the latest, and before any examination carried out within the setting of the study (article L1122-1-1 of the Public Health Code). Non-inclusion criteria * Positive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed. * Symptoms and/or clinical signs consistent with

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

322

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

PrEP

Key resources

2022-01

Identifier

NCT06145854

Link

https://clinicaltrials.gov/study/NCT06145854

Phase

Marketed

Status

Recruiting

Sponsor

Midway Specialty Care Center

More details

Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.

Purpose

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-01-02

Anticipated Date of Last Follow-up
2024-07-26

Estimated Primary Completion Date
2026-10-30

Estimated Completion Date
2027-03-31

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

100

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

PrEP

Key resources

OR-PrEP@Home

Identifier

NCT05949203

Link

https://clinicaltrials.gov/study/NCT05949203

Phase

Not provided

Status

Recruiting

Sponsor

Oregon Health and Science University

More details

This demonstration study will evaluate the real-world implementation of long-acting cabotegravir (CAB-LA) for HIV pre-exposure prevention (PrEP) through a partnership between the OHSU Tele-PrEP Program (TPP) and the OHSU Home Infusion Pharmacy (HIP). The study will perform a formative evaluation of the TPP/HIP partnership to determine its merit and worth, with revisions made as needed to improve the program, which is reflective of a real-world program rollout. The study is observational, and there is no comparison group. The primary objective is to evaluate adherence to CAB-LA by both urban and rural participants using the TPP/HIP partnership. The goals of the study are improve the TPP/HIP program itself with attention to reducing geographic disparities, and to disseminate best practices a

Purpose

Oregon PrEP at Home Study

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-12-01

Anticipated Date of Last Follow-up
2023-12-05

Estimated Primary Completion Date
2025-12-01

Estimated Completion Date
2025-12-01

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

125

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

PrEP

Key resources

TAIL-PrEP

Identifier

NCT06868641

Link

https://clinicaltrials.gov/study/NCT06868641

Phase

Not provided

Status

Not yet recruiting

Sponsor

Columbia University

More details

The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention, which will use cabotegravir drug level monitoring to provide personalized HIV prevention coaching to patients discontinuing long-acting cab-LA. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Purpose

The TAIL-PrEP Study

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2025-03-24

Actual Start Date
Not provided

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

Estimated Primary Completion Date
2026-08-01

Estimated Completion Date
2027-03-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion criteria: * At least 18 years of age * Have discontinued cab-LA injections within the last three months * Not currently on cab-LA injections * HIV-negative (self-report) * Able to speak and read in English or Spanish, * Able to receive and send monthly packages * Have access to an internet-connected device capable of running the Zoom video conferencing platform * Have a private location at which to take Zoom calls The study period will end for patient participants once the monthly blood draw result indicates that cab-LA levels are not detectable (estimated average of 6 months across all patients) or after 6 months of the study, whichever comes first. If at 6 months of study participation, cab-LA levels are still detectable and participants adhered to at least 50% of study activ

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

30

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

PrEP

Key resources

NOTRE

Identifier

NCT06854029

Link

https://clinicaltrials.gov/study/NCT06854029

Phase

Marketed

Status

Not yet recruiting

Sponsor

Duke University

More details

The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Purpose

NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2025-11-01

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2025-02-25

Estimated Primary Completion Date
2029-12-01

Estimated Completion Date
2030-06-01

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: 1. Adults (age 18) at a participating carceral site; 2. Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded; 3. History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration); 4. HIV negative (as confirmed by a HIV rapid test); 5. Clinically indicated for PrEP based on CDC guidelines during incarceration and/or the year prior to incarceration; 6. Willing to enroll in buprenorphine treatment and PrEP and be randomized to

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

300

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Single blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

VIHINJECT

Identifier

NCT06834113

Link

https://clinicaltrials.gov/study/NCT06834113

Phase

Not provided

Status

Recruiting

Sponsor

Centre Hospitalier Régional d'Orléans

More details

This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset. Participants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D). Each pa

Purpose

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-01-24

Anticipated Date of Last Follow-up
2025-05-28

Estimated Primary Completion Date
2026-07-24

Estimated Completion Date
2026-09-24

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: * Patient aged at least 18 years; * Patient infected with HIV-1; * Patient virologically controlled (VL \< 50 copies/ml); * Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician. Exclusion Criteria: * Patient(s) on another injectable antiretroviral treatment; * Patient participating in another clinical trial with medication; * Patient(s) with epilepsy; * Patient on antidepressant treatment; * Patient(s) with psychiatric or behavioral disorders; * Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset; * Patient(s) with visual and hearing impairments that prevent the use of virtual rea

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

120

Allocation

Randomized

Intervention model

Cross-over 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

PrEP

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

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

Bowers GD, Culp A, Reese MJ, Tabolt G, Moss L, Piscitelli S, Huynh P, Wagner D, Ford SL, Gould EP, Pan R, Lou Y, Margolis DA, Spreen WR: Disposition and metabolism of cabotegravir: a comparison of biotransformation and excretion between different species and routes of administration in humans. Xenobiotica. 2016;46(2):147-62. doi: https://doi.org/10.3109/00498254.2015.1060372 Epub 2015 Jul 1

1. Cabotegravir [(3S,11aR)-N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide] is an HIV-1 integrase inhibitor under development as a tablet for both oral lead-in therapy and long-acting (LA) injectable for intramuscular dosing.

2. Metabolism, pharmacokinetics and excretion were investigated in healthy human subjects who received either a single oral dose (28.2 mg) of [14C]cabotegravir in a mass balance study, or LA formulations of unlabeled cabotegravir (200–800 mg), intramuscularly or subcutaneously, in a separate study. Metabolism, distribution and excretion of [14C]cabotegravir were also investigated in mice, rats and monkeys.

3. Recovery of radioactivity in humans represented a mean total of 85.3% of the dose, including 26.8% in the urine. The mean apparent terminal phase half-life was similar for both cabotegravir and radioactivity, 39 h compared to 41 h.

4. Following oral, intramuscular and subcutaneous administration, cabotegravir was the major component in plasma and the glucuronic acid conjugate (M1) represented the predominant component in urine. Cabotegravir was present in bile along with its major metabolite (M1).

5. The primary metabolite of [14C]cabotegravir in mouse, rat and monkey was the same as that in human. In vitro phenotyping experiments demonstrated that cabotegravir was metabolized by UDP-glucuronosyltransferase (UGT) 1A1 and UGT1A9.

Spreen W, Min S, Ford SL, Chen S, Lou Y, Bomar M, St Clair M, Piscitelli S, Fujiwara T: Pharmacokinetics, safety, and monotherapy antiviral activity of GSK1265744, an HIV integrase strand transfer inhibitor. HIV Clin Trials. 2013 Sep-Oct;14(5):192-203. doi: https://doi.org/10.1310/hct1405-192

Background: GSK1265744 is an HIV integrase strand transfer inhibitor selected for clinical development.

Objective: This first-time-in-human and phase IIa investigation assessed GSK1265744 antiviral activity, pharmacokinetics, safety, and tolerability in healthy and HIV-1-infected subjects.

Methods: This double-blind, placebo-controlled study consisted of a dose escalation of single (part A) and multiple (part B) oral doses in 48 healthy subjects and an oral dose (part C) in 11 HIV-1-infected subjects. In part A, 2 cohorts of 9 subjects received either 5 and 25 mg or 10 and 50 mg. In part B, 3 cohorts of 10 subjects received 5, 10, or 25 mg once daily for 14 days. In part C and the phase IIa study, subjects received 5 or 30 mg once daily for 10 days.

Results: Dose-proportional increases in drug exposure were observed in healthy and HIV-1-infected subjects. In healthy subjects, pharmacokinetic variability was low following single or repeat dosing (coefficient of variation, 13%-34% and 15%-23%, respectively). Mean plasma half-life was 31.5 hours. GSK1265744 monotherapy significantly reduced plasma HIV-1 RNA from baseline to day 11 in HIV-1-infected subjects receiving 5 or 30 mg versus placebo (P < .001); mean decrease was 2.2 to 2.3 log10 copies/mL, respectively. Study drug was generally well tolerated with no clinically relevant trends in laboratory values, vital signs, or electrocardiograms.

Conclusions: GSK1265744 was well tolerated in healthy and HIV-1-infected subjects. Results demonstrate once-daily doses of 5 or 30 mg exceeded minimum target therapeutic concentrations and produced a significant reduction in plasma HIV-1 RNA viral load.

Trezza C, Ford SL, Spreen W, Pan R, Piscitelli S. Formulation and pharmacology of long-acting cabotegravir. Curr Opin HIV AIDS. 2015 Jul;10(4):239-45. doi: https://doi.org/10.1097%2FCOH.0000000000000168. PMID: 26049948; PMCID: PMC5638427.

Purpose of review 

Long-acting cabotegravir may provide a novel therapeutic option for both the treatment and prevention of HIV-1 infection that does not necessitate adherence to a daily regimen. The present review will highlight the unique formulation properties and pharmacologic attributes of long-acting cabotegravir nanosuspension.

Recent findings 

Cabotegravir is a potent integrase strand transfer inhibitor that has been formulated as an oral tablet for daily administration and as a long-acting injectable nanosuspension. Long-acting cabotegravir is readily absorbed following intramuscular and subcutaneous administration and has an elimination half-life of approximately 40 days, allowing for administration on a monthly or less frequent schedule. Repeat-dose pharmacokinetic studies and population pharmacokinetic modeling indicate monthly and bi-monthly dosing achieves clinically relevant plasma concentrations considered effective for HIV maintenance therapy and that quarterly injections are appropriate for investigation as preexposure prophylaxis. Cabotegravir is primarily metabolized by uridine diphosphate glucuronosyltransferase 1A1 and is unlikely to be impacted by the cytochrome P450 metabolic pathway. In vitro and in vivo data suggest cabotegravir has a low propensity to cause, or be subject to, significant drug interactions.

Summary 

The pharmacologic profile of long-acting cabotegravir supports its continued development for both treatment and prevention of HIV-1 infection.

Additional documents

• Cabotegravir manufacturing steps

• Tentative timeline generic CAB

• posterHIVR4P

Useful links

• FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

• GSK744 SAFETY DATA SHEET CAYMAN CHEMICALS (PDF)

• World Health Organization Guidelines on long-acting injectable cabotegravir for HIV prevention

• Injectable Cabotegravir for PrEP

• Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial

• Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial

• Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial

• Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial

• Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

• Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial

• Safety, Tolerability, Pharmacokinetics, and Acceptability of Oral and Long-Acting Cabotegravir in HIV-Negative Chinese Men

• Voluntary licence for CAB-La for PrEP ViiV Healthcare - Medicines Patent Pool

• Project website

• Mobile men newsletter July 2025

• Mobile Men newsletter Oct 2024

• Mobile Men Newsletter May 2024

• Mobile Men Newsletter October 2023

• In the Face of a Global Pandemic and Social Barriers, Cisgender Female Adolescents Enroll in HIV Prevention Trial HPTN 084-01 in Sub-Saharan Africa

• HPTN 084-01 website with key publications !

	Collaborate for development Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided
	Share technical information for match-making assessment Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided
	Work with MPP to expand access in LMICs In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided

Cabotegravir LA, both as suspension for intramuscular injection 600mg/3ml (200mg/ml) and as 30 mg tablet is included in WHO PQ: https://extranet.who.int/prequal/sites/default/files/document_files/EOI_23rd%20HIV_9July_2025_clean_PQ.pdf Cabotegravir for PrEP is included in WHO guidelines. CAB+RPV LA injectable for treatment, is also recommended by WHO to be used as an alternative switching option for adults and adolescents with undetectable HIV viral load on oral ART and without active hepatitis B infection : https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/guidelines ViiV Healthcare and Medicines Patent Pool have signed a voluntary licensing agreement to enable access to long-acting injectable cabotegravir for HIV PrEP and HIV treatment https://tinyurl.com/VL-CAB-MPP