NCT07071623RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 4580 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 10 Nov 2025
- Primary completion date
- 18 Oct 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT07071623
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 4580
- From 10 Nov 2025 to the primary completion date, 18 Oct 2027
- 30 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- The main exclusion criteria include but are not limited to the following:
Who the study is looking for
- 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
Age in the registry: 16 years to 30 years · Sex: Female · Accepts healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UW - KNH; Rachuonyo County Hospital ( Site 0006) Coordinator of this site? Confirm its status | Homabay County | Kenya | Recruiting |
| Kargeno Research & Policy Hub ( Site 0007) Coordinator of this site? Confirm its status | Kisumu | Kenya | Recruiting |
| KEMRI-CMR-RCTP ( Site 0003) Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
| Partners in Health and Research Development (PHRD) ( Site 0002) Coordinator of this site? Confirm its status | Thika | Kenya | Active, not recruiting |
| MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064) Coordinator of this site? Confirm its status | Entebbe | Uganda | Recruiting |
| UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067) Coordinator of this site? Confirm its status | Entebbe | Uganda | Recruiting |
| Infectious Diseases Institute Kalangala ( Site 0063) Coordinator of this site? Confirm its status | Kalangala District | Uganda | Recruiting |
| MU-JHU Research Collaboration - Kampala ( Site 0062) Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| MU-JHU Research Collaboration - Mityana ( Site 0061) Coordinator of this site? Confirm its status | Mityana, District | Uganda | Recruiting |
| Josha Research ( Site 0045) Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Active, not recruiting |
| Desmond Tutu Health Foundation. Philippi Village ( Site 0024) Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| DTHF Masiphumelele Clinical Research Site ( Site 0023) Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026) Coordinator of this site? Confirm its status | Chatsworth | South Africa | Active, not recruiting |
| Umlazi Clinical Research Site ( Site 0047) Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035) Coordinator of this site? Confirm its status | Durban | South Africa | Active, not recruiting |
| Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027) Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| CAPRISA eThekwini Clinical Research Site ( Site 0030) Coordinator of this site? Confirm its status | Durban | South Africa | Active, not recruiting |
| Synergy Biomed Research Institute ( Site 0040) Coordinator of this site? Confirm its status | East London | South Africa | Recruiting |
| SYNAPSE Research Clinic ( Site 0043) Coordinator of this site? Confirm its status | Edendale | South Africa | Recruiting |
| Wits RHI Ward 21 Clinical Research site ( Site 0022) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Active, not recruiting |
| Perinatal HIV Research Unit (PHRU) ( Site 0033) Coordinator of this site? Confirm its status | Johnnesburg | South Africa | Recruiting |
| Vuka Research Clinic ( Site 0025) Coordinator of this site? Confirm its status | Khayelitsha | South Africa | Active, not recruiting |
| Qhakaza Mbokodo Research Clinic ( Site 0028) Coordinator of this site? Confirm its status | Ladysmith | South Africa | Recruiting |
| Foundation For Professional Development ( Site 0031) Coordinator of this site? Confirm its status | Ndevana | South Africa | Active, not recruiting |
| SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037) Coordinator of this site? Confirm its status | Phoenix | South Africa | Recruiting |
| CAPRISA Vulindlela Clinical Research Site ( Site 0029) Coordinator of this site? Confirm its status | Pietermaritzburg | South Africa | Recruiting |
| Setshaba Research Centre ( Site 0032) Coordinator of this site? Confirm its status | Pretoria | South Africa | Recruiting |
| Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049) Coordinator of this site? Confirm its status | Somkhele - Mtubatuba | South Africa | Active, not recruiting |
| SA Medical Research Council - Verulam Clinical Research Site ( Site 0036) Coordinator of this site? Confirm its status | Verulam | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.