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
Status: Recruiting
Location: See all (66) 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 as well as or 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: All
Minimum Age: 16
Healthy Volunteers: t
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
• Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
• Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
• Weighs ≥35 kg
Locations
United States
Alabama
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
RECRUITING
Birmingham
USA Health University Hospitals ( Site 0020)
RECRUITING
Mobile
California
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
RECRUITING
Los Angeles
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
RECRUITING
San Francisco
Washington, D.c.
Whitman-Walker Institute ( Site 0016)
RECRUITING
Washington D.c.
Florida
University of Miami RAPID Research ( Site 0003)
RECRUITING
Miami
Orlando Immunology Center ( Site 0021)
RECRUITING
Orlando
Georgia
Hope Clinic of the Emory Vaccine Center ( Site 0009)
RECRUITING
Decatur
Illinois
University of Illinois Chicago ( Site 0027)
RECRUITING
Chicago
Louisiana
University Medical Center New Orleans ( Site 0024)
RECRUITING
New Orleans
Mississippi
Open Arms Healthcare Center ( Site 0025)
RECRUITING
Jackson
North Carolina
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
RECRUITING
Chapel Hill
Regional Center for Infectious Diseases ( Site 0018)
RECRUITING
Greensboro
New Jersey
Rutgers New Jersey Medical School ( Site 0010)
RECRUITING
Newark
New York
Montefiore Medical Center ( Site 0017)
RECRUITING
The Bronx
Pennsylvania
Philadelphia Fight Community Health Centers ( Site 0011)
RECRUITING
Philadelphia
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
RECRUITING
Pittsburgh
South Carolina
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
RECRUITING
Columbia
Tennessee
St. Jude Children's Research Hospital ( Site 0026)
RECRUITING
Memphis
Meharry Medical College ( Site 0013)
RECRUITING
Nashville
Texas
Central Texas Clinical Research ( Site 0014)
RECRUITING
Austin
Saint Hope Foundation, Inc. ( Site 0015)
RECRUITING
Bellaire
Washington
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
RECRUITING
Seattle
Other Locations
Argentina
Fundación IDEAA ( Site 0351)
RECRUITING
Buenos Aires
Centro de Estudios Infectológicos S.A. ( Site 0357)
RECRUITING
Caba
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
RECRUITING
Caba
Fundación Huésped ( Site 0350)
RECRUITING
Caba
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
RECRUITING
Mar Del Plata
Brazil
School of Medicine Federal University of Minas Gerais ( Site 0417)
RECRUITING
Belo Horizonte
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
RECRUITING
Manaus
Hospital Geral de Nova Iguacu ( Site 0411)
RECRUITING
Nova Iguaçu
Obras Sociais Irma Dulce ( Site 0406)
RECRUITING
Salvador
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
RECRUITING
São Paulo
Hospital das Clinicas FMUSP ( Site 0401)
RECRUITING
São Paulo
Ricardo Diaz Scientific Solutions ( Site 0402)
RECRUITING
São Paulo
Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
RECRUITING
Santiago
Universidad San Sebastian - Providencia ( Site 0454)
RECRUITING
Santiago
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
RECRUITING
Temuco
Colombia
Clinica de la Costa S.A.S. ( Site 0501)
RECRUITING
Barranquilla
Hospital Universitario San Ignacio ( Site 0503)
RECRUITING
Bogotá
Fundación Valle del Lili ( Site 0502)
RECRUITING
Cali
IPS SURA San Diego ( Site 0500)
RECRUITING
Medellín
Dominican Republic
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
RECRUITING
Santo Domingo
Endocardio ( Site 1003)
RECRUITING
Santo Domingo
Instituto Dermatológico y Cirugía de Piel Dr. Huberto Bogaert Díaz ( Site 1002)
RECRUITING
Santo Domingo De Guzman
France
Hopital Bichat - Claude Bernard ( Site 0101)
RECRUITING
Paris
Hopital Saint Louis ( Site 0100)
RECRUITING
Paris
Hôpital Tenon ( Site 0102)
RECRUITING
Paris
Guatemala
CELAN,S.A ( Site 1052)
RECRUITING
Guatemala City
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
RECRUITING
Guatemala City
MEDI-K ( Site 1053)
RECRUITING
Guatemala City
Malaysia
Universiti Malaya Medical Centre ( Site 0651)
RECRUITING
Kuala Lumpur
Peru
Via Libre ( Site 0551)
RECRUITING
Lima
South Africa
Desmond Tutu Health Foundation ( Site 0250)
RECRUITING
Cape Town
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
RECRUITING
Durban
Wits RHI Research Center ( Site 0251)
RECRUITING
Johannesburg
Foundation For Professional Development ( Site 0257)
RECRUITING
King Williams Town
Setshaba Research Centre ( Site 0252)
RECRUITING
Pretoria
Perinatal HIV Research Unit (PHRU) ( Site 0253)
RECRUITING
Soweto
Switzerland
University Hospital Basel ( Site 1102)
RECRUITING
Basel
Inselspital Bern ( Site 1103)
RECRUITING
Bern
Checkpoint Zurich ( Site 1100)
RECRUITING
Zurich
Thailand
Chulalongkorn Hospital ( Site 0807)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 0806)
RECRUITING
Bangkok
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
RECRUITING
Bangkok
Research Institute for Health Sciences ( Site 0809)
RECRUITING
Muang
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2027-07-22
Participants
Target number of participants: 4390
Treatments
Experimental: MK-8527
Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to 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
Participants will receive 200 mg FTC/245 mg TDF QD and placebo 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