Clinical Research Directory
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A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Sponsor: Merck Sharp & Dohme LLC
Summary
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
Official title: 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
Key Details
Gender
FEMALE
Age Range
16 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
4580
Start Date
2025-11-10
Completion Date
2027-10-18
Last Updated
2026-03-30
Healthy Volunteers
Yes
Interventions
MK-8527
Oral tablet
Emtricitabine/tenofovir disoproxil (FTC/TDF)
Oral tablet
Placebo matched to MK-8527
Placebo oral tablet matched to MK-8527
Placebo matched to FTC/TDF
Placebo oral tablet matched to FTC/TDF
Locations (29)
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
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