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
- Entebbe, Kalangala District, Kampala, and Mityana, District, UgandaSee the 5 sites
- Phase
- Phase 3
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 Uganda
- MRC/UVRI and LSHTM Uganda Research Unit Masaka (Site 0064)Entebbe, UgandaTaking people
- UVRI Clinical Research Program Initiative Ltd (UVRI CRP) (Site 0067)Entebbe, UgandaTaking people
- Infectious Diseases Institute Kalangala (Site 0063)Kalangala District, UgandaTaking people
- MU-JHU Research Collaboration - Kampala (Site 0062)Kampala, UgandaTaking people
- MU-JHU Research Collaboration - Mityana (Site 0061)Mityana, District, UgandaTaking people
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:.