Clinical trials
MK-8527-007 - QM PrEP
Identifier
NCT06045507
Link
https://clinicaltrials.gov/study/NCT06045507
Phase
Phase II
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
Purpose
Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection.
Interventions
Intervention 1
MK-8527 Low Dose QM for 6 months
Dosage: 3mg oral capsule
Intervention 2
Medium Dose QM for 6 months
Dosage: 6mg oral capsule
Intervention 3
MK-8527 High Dose QM for 6 months
Dosage: 12mg oral capsule
Intervention 4
Placebo to MK-8527 for 6 months
Dosage: oral capsule
Countries
United States of America
Israel
South Africa
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-11-08
Anticipated Date of Last Follow-up
2025-03-11
Estimated Primary Completion Date
2025-02-18
Estimated Completion Date
2025-02-18
Actual Primary Completion Date
2024-12-12
Actual Completion Date
2025-02-12
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied
populations
Participants aged 18 to 65 years who are confirmed HIV-uninfected with low-risk of acquiring HIV.
Participants are excluded if they have prior use of either islatravir (MK-8591) or MK-8527.
Health status
Considered at low risk of
: HIV
Negative to
: HIV, HCV, HBV
Other health status: excluded if previous use of islatravir or MK-8527
Study type
Interventional (clinical trial)
Enrollment
352
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Participants receive the intervention for 6 months and are then followed-up for 8 weeks blinded safety period.
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Monthly
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
MK-8527-002 - monotherapy antiviral
Identifier
NCT03615183
Link
https://clinicaltrials.gov/study/NCT03615183
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Purpose
Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants.
Interventions
Intervention 1
A-MK-8527
Dosage: Single oral dose of 10 mg MK-8527 capsule after an 8-hour fast
Intervention 2
B-MK-8527
Dosage: Single oral dose of 3 mg MK-8527 capsule after an 8-hour fast
Intervention 3
C-MK-8527
Dosage: Single oral dose of 1 mg MK-8527 capsule after an 8-hour fast
Intervention 4
MK-8527
Dosage: Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast
Intervention 5
MK-8527
Dosage: Another single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast.
Countries
Romania
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-02-11
Anticipated Date of Last Follow-up
2020-09-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-09-26
Actual Completion Date
2019-09-26
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Participants are ART-naïve HIV-1 positive individuals with a Body Mass Index (BMI) ≤35 kg/m^2, inclusive.
Health status
Negative to
: HCV, HBV
Positive to
: HIV
Other health status: Diagnosed with HIV-1 infection ≥ 3 months prior to screening
Study type
Interventional (clinical trial)
Enrollment
17
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
None (Open Label)
Frequency of administration
Once
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
MK-8527-004 - monotherapy antiviral
Identifier
NCT05494736
Link
https://clinicaltrials.gov/study/NCT05494736
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
Purpose
Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of a Single Dose of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants.
Interventions
Intervention 1
A-MK-8527
Dosage: single oral dose of MK-8527 1.0 mg
Intervention 2
C-MK-8527
Dosage: single oral dose of MK-8527 0.25 mg
Intervention 3
B-MK-8527
Dosage: single oral dose of MK-8527 0.5 mg
Countries
Romania
South Africa
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-11-17
Anticipated Date of Last Follow-up
2025-03-06
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
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Participants are ART-naïve HIV-1 positive individuals aged 18-60 years.
Health status
Negative to
: HBV, HCV
Positive to
: HIV
Study type
Interventional (clinical trial)
Enrollment
20
Allocation
Non-randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
None (Open Label)
Frequency of administration
Other/Variable/Unknown
:
"Single dose
"
Once
Monthly
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
MK-8527-008 - renal impairment
Identifier
NCT06295796
Link
https://clinicaltrials.gov/study/NCT06295796
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.
Purpose
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
Interventions
Intervention 1
MK-8527
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-06-20
Anticipated Date of Last Follow-up
2025-02-05
Estimated Primary Completion Date
2024-03-06
Estimated Completion Date
2024-03-06
Actual Primary Completion Date
2025-01-31
Actual Completion Date
2025-01-31
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Moderate and Severe RI
* With the exception of RI, is in sufficient health for study participation.
* Has stable renal function.
Healthy
* Matches mean age to participants with moderate and severe RI.
* Has normal renal function.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants
* History of cancer (malignancy).
* Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
* Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
* Donated plasma within 7 days prior to dosing.
Moderate and Severe RI
* Failed renal transplant or h
Health status
Not provided
Other health status: Participants With Moderate and Severe Renal Impairment
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Non-randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
MK-8527-012 - CBZ
Identifier
NCT06893081
Link
https://clinicaltrials.gov/study/NCT06893081
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ. Carbamazepine, sold under the brand name Tegretol among others, is an anticonvulsant medication used in the treatment of epilepsy and neuropathic pain. It is used as an adjunctive treatment in schizophrenia along with other medications and as a second-line agent in bipolar disorder.
Purpose
A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
Interventions
Intervention 1
MK-8527
Intervention 2
CBZ
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-04-28
Actual Start Date
2025-04-28
Anticipated Date of Last Follow-up
2025-07-28
Estimated Primary Completion Date
2025-06-19
Estimated Completion Date
2025-07-11
Actual Primary Completion Date
2025-06-19
Actual Completion Date
2025-07-17
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
Inclusion criteria include, but are not limited to:
* Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive
* Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
* Has a history or presence of:
* Seizures (except for febrile seizure), or is at an increased risk for seizures
* Family history of severe dermatologic reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome
* Clinically meaningful hematologic diseases, bone marrow disorders, or hematologic adverse reactions to other medications
* Depression, unusual changes in mood or behavior or suicidal thoughts
Health status
Negative to
: HIV
Study type
Interventional (clinical trial)
Enrollment
16
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
MK-8527-005 - multiple dose PK
Identifier
EUCT2022-502081-24-00
Link
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2022-502081-24-00
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
A Multiple-Dose Clinical Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-8527 in Healthy Participants
Purpose
A Multiple-Dose Clinical Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-8527 in Healthy Participants
Interventions
Intervention 1
MK-8527
Countries
Belgium
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2022-12-07
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2023-06-14
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
18-64 years
Health status
Negative to
: HIV
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
MK-8527-013 - PK/PD
Identifier
NCT06826989
Link
https://clinicaltrials.gov/study/NCT06826989
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn how MK-8527 moves through a healthy person's body over time. Researchers will study how MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.
Purpose
A Study of MK-8527 in Healthy Adult Participants (PK PD) (MK-8527-013)
Interventions
Intervention 1
MK-8527
Dosage: single oral dose
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-03-19
Anticipated Date of Last Follow-up
2025-06-10
Estimated Primary Completion Date
2025-05-07
Estimated Completion Date
2025-05-21
Actual Primary Completion Date
2025-06-04
Actual Completion Date
2025-06-04
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Is in good health
* Has a body mass index (BMI) of 18 to 32 kg/m\^2
Exclusion Criteria:
* Has a history of cancer
* Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
Health status
Negative to
: HBV, HCV, HIV
Other health status: body mass index (BMI) of 18 to 32 kg/m^2
Study type
Interventional (clinical trial)
Enrollment
8
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Monthly
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
MK-8527-009 - Breast Milk
Identifier
NCT06580587
Link
https://clinicaltrials.gov/study/NCT06580587
Phase
Phase I
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
Purpose
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
Interventions
Intervention 1
MK-8527 oral single dose
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-04-15
Anticipated Date of Last Follow-up
2025-04-21
Estimated Primary Completion Date
2025-12-19
Estimated Completion Date
2025-12-19
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
Yes
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
* Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate
* Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment
* Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrit
Health status
Negative to
: HBV, HCV, HIV
Other health status: Healthy Lactating Female Participants
Study type
Interventional (clinical trial)
Enrollment
12
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
MK-8527-006 - LNG/EE
Identifier
NCT06783192
Link
https://clinicaltrials.gov/study/NCT06783192
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
Purpose
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.
Interventions
Intervention 1
MK-8527
Intervention 2
LNG/EE levonorgestrel/ethinyl estradiol combination tablet taken by mouth
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-08-14
Anticipated Date of Last Follow-up
2025-01-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-10-11
Actual Completion Date
2023-10-11
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
18 Years to 70 Years (Adult, Older Adult )
* is in good overall health
* assigned female at birth
Exclusion Criteria:
* has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
* has a history of cancer (malignancy)
Health status
Negative to
: HIV, HCV, HBV
Study type
Interventional (clinical trial)
Enrollment
14
Allocation
Non-randomized
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
|
Type
|
Title |
Content |
Link |
|
Link
|
Phase 1, open-label study to evaluate the drug interaction between MK-8527, an HIV-1 nucleoside reverse transcriptase translocation inhibitor, and the oral contraceptive levonorgestrel/ethinyl estradi
|
|
https://www.natap.org/2024/IAS/IAS_115.htm
|
MK-8527-016 - TDF/FTC
Identifier
NCT06816043
Link
https://clinicaltrials.gov/study/NCT06816043
Phase
Phase I
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).
Purpose
A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants
Interventions
Intervention 1
MK-8527
Dosage: oral capsule
Intervention 2
FTC/TDF + MK-8527
Dosage: oral tablet + oral capsule
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-02-21
Anticipated Date of Last Follow-up
2025-06-25
Estimated Primary Completion Date
2025-06-05
Estimated Completion Date
2025-06-05
Actual Primary Completion Date
2025-06-05
Actual Completion Date
2025-06-17
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
* Has body mass index (BMI) ≥18 and ≤32.0 kg/m\^2
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease
* History of cancer (malignancy)
* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Health status
Negative to
: HIV, HCV, HBV
Other health status: 19 Years to 55 Years (Adult ) Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior Has body mass index (BMI) ≥18 and ≤32.0 kg/m^2
Study type
Interventional (clinical trial)
Enrollment
20
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Monthly
Studied LA-formulation(s)
Other(s)
:
"Oral Capsule
"
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
MK-8527-011 -EXPrESSIVE-11
Identifier
NCT07044297
Link
https://clinicaltrials.gov/study/NCT07044297
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The goals of this study are to learn:
* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
* About the safety of MK-8527 and if people tolerate it
Purpose
A Clinical Study of MK-8527 to Prevent HIV-1: study toefficacy, safety, and tolerability of MK-8527 compared to daily oral PrEP (TDF/FTC).
Interventions
Intervention 1
MK-8527 oral tablet
Dosage: 11 mg MK-8527 once monthly (QM)
Intervention 2
Placebo to MK-8527
Intervention 3
FTC/TDF
Dosage: 200 mg FTC/245 mg TDF QD
Intervention 4
Placebo to FTC/TDF
Countries
United States of America
Argentina
Brazil
Chile
Colombia
Dominican Republic
France
Guatemala
Kenya
Malaysia
Peru
Philippines
South Africa
Switzerland
Thailand
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-07-31
Actual Start Date
2025-07-31
Anticipated Date of Last Follow-up
2025-09-09
Estimated Primary Completion Date
2027-10-20
Estimated Completion Date
2027-10-20
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion criteria include:
* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
* Weighs ≥35 kg
Health status
Negative to
: HIV, HBV
Other health status: 4,390 cisgender men who have sex with men, transgender men, transgender women, and gender non binary individuals 16 Years and older
Study type
Interventional (clinical trial)
Enrollment
4390
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Tablet
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
MK-8527-015 -Hepatic Impairment
Identifier
NCT07025551
Link
https://clinicaltrials.gov/study/NCT07025551
Phase
Phase I
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
Purpose
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
Interventions
Not provided
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-09-08
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-08-27
Estimated Primary Completion Date
2025-12-08
Estimated Completion Date
2026-01-07
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
All participants:
* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\^2
* Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
* Has mild or moderate hepatic impairment
* Is generally in good health with the exception of HI
Healthy Control Participants (Group 3):
- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs
Exclusion Criteria:
The main exclusion criteria include but
Health status
Negative to
: HIV, HBV, HCV, oncology
Other health status: Researchers will compare what happens to MK-8527 in the body when it is given to participants with mild and moderate hepatic (liver) impairment.
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Tablet
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
MK-8527-014 -Moxifloxacin -QT
Identifier
NCT07063238
Link
https://clinicaltrials.gov/study/NCT07063238
Phase
Phase I
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.
MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.
The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
Purpose
A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
Interventions
Intervention 1
MK-8527+Moxifloxacin+Placebo
Dosage: sequential
Intervention 2
Moxifloxacin+MK-8527+Placebo
Dosage: sequential
Intervention 3
Placebo+MK-8527+Moxifloxacin
Dosage: sequential
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-07-22
Actual Start Date
2025-08-12
Anticipated Date of Last Follow-up
2025-08-20
Estimated Primary Completion Date
2025-11-25
Estimated Completion Date
2025-11-25
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Is in good health before randomization
* Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
* Has history of cancer (malignancy).
* Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Health status
Negative to
: HIV, HBV, HCV, oncology
Study type
Interventional (clinical trial)
Enrollment
42
Allocation
Randomized
Intervention model
Cross-over assignment
Intervention
model description
Not provided
Masking
Double-blind masking
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
Not provided
MK-8527-010 -EXPrESSIVE-10
Identifier
NCT07071623
Link
https://clinicaltrials.gov/study/NCT07071623
Phase
Phase III
Status
Not yet recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.
The goals of this study are to learn:
* If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
* About the safety of MK-8527 and if people tolerate it
Purpose
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Interventions
Intervention 1
MK-8527
Dosage: 11 mg MK-8527 once monthly (QM)
Intervention 2
Placebo matched to MK-8527
Intervention 3
Emtricitabine/tenofovir disoproxil (FTC/TDF)
Dosage: once daily (QD)
Intervention 4
Placebo matched to FTC/TDF
Countries
Kenya
South Africa
Uganda
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-10-31
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-08-26
Estimated Primary Completion Date
2027-10-18
Estimated Completion Date
2027-10-18
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
The main inclusion criteria include:
* Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results
* Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)
* Was assigned female sex at birth and is cisgender.
* Weighs ≥35 kg
Exclusion Criteria include:
* Has hypersensitivity or other contraindication to any component of the study interventions
* Has evidence of acute or chronic hepatitis B infection
* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
*Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
Health status
Negative to
: HIV, HBV
Other health status: 16 Years to 30 Years cisgender women
Study type
Interventional (clinical trial)
Enrollment
4580
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Tablet
Studied route(s) of administration
Oral
Use case
PrEP
Key resources
Not provided
