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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07071623

Registry updated: 2026-10-20
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Description

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

  • MK-8527 (Drug)
    Oral tablet
  • Emtricitabine/tenofovir disoproxil (FTC/TDF) (Drug)
    Oral tablet
  • Placebo matched to MK-8527 (Drug)
    Placebo oral tablet matched to MK-8527
  • Placebo matched to FTC/TDF (Drug)
    Placebo oral tablet matched to FTC/TDF

Eligibility criteria

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 exclusion criteria include but are not limited to the following: * 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 * 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

Conditions

Human Immunodeficiency Virus (HIV) HIV Pre-Exposure Prophylaxis

Locations

  • UW - KNH; Rachuonyo County Hospital ( Site 0006) — Homabay County, Homa Bay County, Kenya
  • Partners in Health and Research Development (PHRD) ( Site 0002) — Thika, Kiambu County, Kenya
  • KEMRI-CMR-RCTP ( Site 0003) — Nairobi, Kisumu County, Kenya
  • Kargeno Research & Policy Hub ( Site 0007) — Kisumu, Kenya
  • Synergy Biomed Research Institute ( Site 0040) — East London, Eastern Cape, South Africa
  • Foundation For Professional Development ( Site 0031) — Ndevana, Eastern Cape, South Africa
  • Josha Research ( Site 0045) — Bloemfontein, Free State, South Africa
  • Wits RHI Ward 21 Clinical Research site ( Site 0022) — Johannesburg, Gauteng, South Africa
  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048) — Johannesburg, Gauteng, South Africa
  • Perinatal HIV Research Unit (PHRU) ( Site 0033) — Johnnesburg, Gauteng, South Africa
  • Setshaba Research Centre ( Site 0032) — Pretoria, Gauteng, South Africa
  • SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026) — Chatsworth, KwaZulu-Natal, South Africa
  • SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035) — Durban, KwaZulu-Natal, South Africa
  • CAPRISA eThekwini Clinical Research Site ( Site 0030) — Durban, KwaZulu-Natal, South Africa
  • Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027) — Durban, KwaZulu-Natal, South Africa
  • Umlazi Clinical Research Site ( Site 0047) — Durban, KwaZulu-Natal, South Africa
  • SYNAPSE Research Clinic ( Site 0043) — Edendale, KwaZulu-Natal, South Africa
  • Qhakaza Mbokodo Research Clinic ( Site 0028) — Ladysmith, KwaZulu-Natal, South Africa
  • SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037) — Phoenix, KwaZulu-Natal, South Africa
  • CAPRISA Vulindlela Clinical Research Site ( Site 0029) — Pietermaritzburg, KwaZulu-Natal, South Africa
  • Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049) — Somkhele - Mtubatuba, KwaZulu-Natal, South Africa
  • SA Medical Research Council - Verulam Clinical Research Site ( Site 0036) — Verulam, KwaZulu-Natal, South Africa
  • Desmond Tutu Health Foundation. Philippi Village ( Site 0024) — Cape Town, Western Cape, South Africa
  • DTHF Masiphumelele Clinical Research Site ( Site 0023) — Cape Town, Western Cape, South Africa
  • Vuka Research Clinic ( Site 0025) — Khayelitsha, Western Cape, South Africa
  • MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064) — Entebbe, Central Region, Uganda
  • Infectious Diseases Institute Kalangala ( Site 0063) — Kalangala District, Kalangala, Uganda
  • MU-JHU Research Collaboration - Mityana ( Site 0061) — Mityana, District, Mityana, Uganda
  • UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067) — Entebbe, Wakiso, Uganda
  • MU-JHU Research Collaboration - Kampala ( Site 0062) — Kampala, Uganda
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record