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
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 30
Healthy Volunteers: t
View:
⁃ 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
Locations
Other Locations
Kenya
UW - KNH; Rachuonyo County Hospital ( Site 0006)
RECRUITING
Homabay County
Kargeno Research & Policy Hub ( Site 0007)
RECRUITING
Kisumu
KEMRI-CMR-RCTP ( Site 0003)
RECRUITING
Nairobi
Partners in Health and Research Development (PHRD) ( Site 0002)
RECRUITING
Thika
South Africa
Josha Research ( Site 0045)
RECRUITING
Bloemfontein
Desmond Tutu Health Foundation. Philippi Village ( Site 0024)
RECRUITING
Cape Town
DTHF Masiphumelele Clinical Research Site ( Site 0023)
RECRUITING
Cape Town
SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)
RECRUITING
Chatsworth
CAPRISA eThekwini Clinical Research Site ( Site 0030)
RECRUITING
Durban
SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)
RECRUITING
Durban
Umlazi Clinical Research Site ( Site 0047)
RECRUITING
Durban
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)
RECRUITING
Durban
Synergy Biomed Research Institute ( Site 0040)
RECRUITING
East London
SYNAPSE Research Clinic ( Site 0043)
RECRUITING
Edendale
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)
RECRUITING
Johannesburg
Wits RHI Ward 21 Clinical Research site ( Site 0022)
RECRUITING
Johannesburg
Perinatal HIV Research Unit (PHRU) ( Site 0033)
RECRUITING
Johnnesburg
Vuka Research Clinic ( Site 0025)
RECRUITING
Khayelitsha
Qhakaza Mbokodo Research Clinic ( Site 0028)
RECRUITING
Ladysmith
Foundation For Professional Development ( Site 0031)
RECRUITING
Ndevana
SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)
RECRUITING
Phoenix
CAPRISA Vulindlela Clinical Research Site ( Site 0029)
RECRUITING
Pietermaritzburg
Setshaba Research Centre ( Site 0032)
RECRUITING
Pretoria
Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)
RECRUITING
Somkhele - Mtubatuba
SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)
RECRUITING
Verulam
Uganda
UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)
RECRUITING
Entebbe
Infectious Diseases Institute Kalangala ( Site 0063)
RECRUITING
Kalangala District
MU-JHU Research Collaboration - Kampala ( Site 0062)
RECRUITING
Kampala
MU-JHU Research Collaboration - Mityana ( Site 0061)
RECRUITING
Mityana, District
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2027-10-18
Participants
Target number of participants: 4580
Treatments
Experimental: MK-8527 + Placebo to FTC/TDF
Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
Active_comparator: FTC/TDF + Placebo to MK-8527
Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC