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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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UW - KNH; Rachuonyo County Hospital ( Site 0006)
Coordinator of this site? Confirm its status
Homabay CountyKenyaRecruiting
Kargeno Research & Policy Hub ( Site 0007)
Coordinator of this site? Confirm its status
KisumuKenyaRecruiting
KEMRI-CMR-RCTP ( Site 0003)
Coordinator of this site? Confirm its status
NairobiKenyaRecruiting
Partners in Health and Research Development (PHRD) ( Site 0002)
Coordinator of this site? Confirm its status
ThikaKenyaActive, not recruiting
MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064)
Coordinator of this site? Confirm its status
EntebbeUgandaRecruiting
UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)
Coordinator of this site? Confirm its status
EntebbeUgandaRecruiting
Infectious Diseases Institute Kalangala ( Site 0063)
Coordinator of this site? Confirm its status
Kalangala DistrictUgandaRecruiting
MU-JHU Research Collaboration - Kampala ( Site 0062)
Coordinator of this site? Confirm its status
KampalaUgandaRecruiting
MU-JHU Research Collaboration - Mityana ( Site 0061)
Coordinator of this site? Confirm its status
Mityana, DistrictUgandaRecruiting
Josha Research ( Site 0045)
Coordinator of this site? Confirm its status
BloemfonteinSouth AfricaActive, not recruiting
Desmond Tutu Health Foundation. Philippi Village ( Site 0024)
Coordinator of this site? Confirm its status
Cape TownSouth AfricaRecruiting
DTHF Masiphumelele Clinical Research Site ( Site 0023)
Coordinator of this site? Confirm its status
Cape TownSouth AfricaRecruiting
SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)
Coordinator of this site? Confirm its status
ChatsworthSouth AfricaActive, not recruiting
Umlazi Clinical Research Site ( Site 0047)
Coordinator of this site? Confirm its status
DurbanSouth AfricaRecruiting
SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)
Coordinator of this site? Confirm its status
DurbanSouth AfricaActive, not recruiting
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)
Coordinator of this site? Confirm its status
DurbanSouth AfricaRecruiting
CAPRISA eThekwini Clinical Research Site ( Site 0030)
Coordinator of this site? Confirm its status
DurbanSouth AfricaActive, not recruiting
Synergy Biomed Research Institute ( Site 0040)
Coordinator of this site? Confirm its status
East LondonSouth AfricaRecruiting
SYNAPSE Research Clinic ( Site 0043)
Coordinator of this site? Confirm its status
EdendaleSouth AfricaRecruiting
Wits RHI Ward 21 Clinical Research site ( Site 0022)
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaRecruiting
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaActive, not recruiting
Perinatal HIV Research Unit (PHRU) ( Site 0033)
Coordinator of this site? Confirm its status
JohnnesburgSouth AfricaRecruiting
Vuka Research Clinic ( Site 0025)
Coordinator of this site? Confirm its status
KhayelitshaSouth AfricaActive, not recruiting
Qhakaza Mbokodo Research Clinic ( Site 0028)
Coordinator of this site? Confirm its status
LadysmithSouth AfricaRecruiting
Foundation For Professional Development ( Site 0031)
Coordinator of this site? Confirm its status
NdevanaSouth AfricaActive, not recruiting
SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)
Coordinator of this site? Confirm its status
PhoenixSouth AfricaRecruiting
CAPRISA Vulindlela Clinical Research Site ( Site 0029)
Coordinator of this site? Confirm its status
PietermaritzburgSouth AfricaRecruiting
Setshaba Research Centre ( Site 0032)
Coordinator of this site? Confirm its status
PretoriaSouth AfricaRecruiting
Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)
Coordinator of this site? Confirm its status
Somkhele - MtubatubaSouth AfricaActive, not recruiting
SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)
Coordinator of this site? Confirm its status
VerulamSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.