Tests a once-monthly pill to prevent HIV-1 in women
Tests MK-8527, a monthly pill, against daily PrEP to prevent HIV-1.
Plain-language title generated from the registry record
Registry title: A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Key facts
- Where
- Homabay County, Kisumu, Nairobi, and Thika, KenyaSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 16 to 30 who do not have HIV and have recently had vaginal sex with a cisgender man. It tests a once-monthly pill to prevent HIV-1.
- Age
- 16 to 30 years
- Sex
- Women only (assigned female at birth and cisgender)
- Disease stage
- No HIV infection: negative HIV-1/HIV-2 test results.
- Earlier treatment
- Must not have ever taken cabotegravir, lenacapavir or any other long-acting HIV prevention product. Must not have had an HIV vaccine at any time, or monoclonal antibodies to HIV within 12 months before Day 1.
- Biomarker or test result
- Negative HIV-1/HIV-2 test results. Body weight of 35 kg (77 lb) or more.
Main reasons for not taking part
- Allergy or other reason not to take any part of the study treatment
- Acute or chronic hepatitis B infection
- Cancer within 5 years of screening, except treated basal or squamous cell skin cancer or in situ cervical cancer
- Needs any prohibited therapies from 30 days before Day 1 through the study
- Past HIV vaccine or monoclonal antibodies to HIV within 12 months before Day 1
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 30 years old?
Source: NCT07071623, who can take part
Where in Kenya
- UW - KNH; Rachuonyo County Hospital (Site 0006)Homabay County, KenyaTaking people
- Kargeno Research & Policy Hub (Site 0007)Kisumu, KenyaTaking people
- KEMRI-CMR-RCTP (Site 0003)Nairobi, KenyaTaking people
- Partners in Health and Research Development (PHRD) (Site 0002)Thika, KenyaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07071623
- Record updated
- 20 October 2026
- Original description
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.Read full original descriptionShow less
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
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
Inclusion: 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: Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration; Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1; 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; The main exclusion criteria include but are not limited to the following:.