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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis

In brief

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

Key facts

Study ID

NCT07071623

Run by

Merck Sharp & Dohme LLC

People needed

4580

Starts

2025-11-10

Expected to finish

2027-10-18

Last updated by the study team

2026-07-20

Who can join

Age: 16 and older, up to 30. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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