A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07071623

Enrollment

4580

Registered

2025-07-17

Start date

2025-11-10

Completion date

2027-10-18

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis

Brief summary

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

Interventions

DRUGMK-8527

Oral tablet

DRUGEmtricitabine/tenofovir disoproxil (FTC/TDF)

Oral tablet

DRUGPlacebo matched to MK-8527

Placebo oral tablet matched to MK-8527

DRUGPlacebo matched to FTC/TDF

Placebo oral tablet matched to FTC/TDF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

The main inclusion criteria include but are not limited to the following: * 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

The main

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection	Up to ~2 years	The number of participants with adjudicated HIV-1 infection will be presented.
Number of Participants who Experience At Least One Adverse Event (AE)	Up to ~2 years	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be presented.
Number of Participants who Discontinue Study Intervention Due to an AE	Up to ~2 years	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be presented.

Countries

Kenya, South Africa, Uganda

Contacts

CONTACTToll Free Number

Trialsites@msd.com1-888-577-8839

STUDY_DIRECTORMedical Director

Merck Sharp & Dohme LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026