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A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
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 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
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
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4390
Start Date
2025-07-31
Completion Date
2027-07-22
Last Updated
2026-04-06
Healthy Volunteers
Yes
Interventions
MK-8527
Oral tablet
FTC/TDF
Oral tablet
Placebo to MK-8527
Placebo tablet matched to MK-8527
Placebo to FTC/TDF
Placebo tablet matched to FTC/TDF
Locations (78)
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham, Alabama, United States
USA Health University Hospitals ( Site 0020)
Mobile, Alabama, United States
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles, California, United States
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco, California, United States
Whitman-Walker Institute ( Site 0016)
Washington D.C., District of Columbia, United States
University of Miami RAPID Research ( Site 0003)
Miami, Florida, United States
Orlando Immunology Center ( Site 0021)
Orlando, Florida, United States
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur, Georgia, United States
University of Illinois Chicago ( Site 0027)
Chicago, Illinois, United States
University Medical Center New Orleans ( Site 0024)
New Orleans, Louisiana, United States
Open Arms Healthcare Center ( Site 0025)
Jackson, Mississippi, United States
Rutgers New Jersey Medical School ( Site 0010)
Newark, New Jersey, United States
Montefiore Medical Center ( Site 0017)
The Bronx, New York, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill, North Carolina, United States
Regional Center for Infectious Diseases ( Site 0018)
Greensboro, North Carolina, United States
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh, Pennsylvania, United States
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia, South Carolina, United States
St. Jude Children's Research Hospital ( Site 0026)
Memphis, Tennessee, United States
Meharry Medical College ( Site 0013)
Nashville, Tennessee, United States
Central Texas Clinical Research ( Site 0014)
Austin, Texas, United States
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire, Texas, United States
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle, Washington, United States
Centro de Estudios Infectológicos S.A. ( Site 0357)
CABA, Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
CABA, Buenos Aires, Argentina
Fundación Huésped ( Site 0350)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
Mar del Plata, Buenos Aires, Argentina
Fundación IDEAA ( Site 0351)
Buenos Aires, Argentina
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
Manaus, Amazonas, Brazil
Obras Sociais Irma Dulce ( Site 0406)
Salvador, Estado de Bahia, Brazil
School of Medicine Federal University of Minas Gerais ( Site 0417)
Belo Horizonte, Minas Gerais, Brazil
Hospital Geral de Nova Iguacu ( Site 0411)
Nova Iguaçu, Rio de Janeiro, Brazil
Ricardo Diaz Scientific Solutions ( Site 0402)
São Paulo, São Paulo, Brazil
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
São Paulo, São Paulo, Brazil
Hospital das Clinicas FMUSP ( Site 0401)
São Paulo, São Paulo, Brazil
Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)
Rio de Janeiro, Brazil
Universidad San Sebastian - Providencia ( Site 0454)
Santiago, Region M. de Santiago, Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
Santiago, Region M. de Santiago, Chile
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
Temuco, Región de la Araucanía, Chile
IPS SURA San Diego ( Site 0500)
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 0501)
Barranquilla, Atlántico, Colombia
Hospital Universitario San Ignacio ( Site 0503)
Bogotá, Bogota D.C., Colombia
Fundación Valle del Lili ( Site 0502)
Cali, Valle del Cauca Department, Colombia
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo, Nacional, Dominican Republic
Endocardio ( Site 1003)
Santo Domingo, Nacional, Dominican Republic
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)
Santo Domingo de Guzman, Santo Domingo Province, Dominican Republic
Hopital Saint Louis ( Site 0100)
Paris, France
Hôpital Tenon ( Site 0102)
Paris, France
Hopital Bichat - Claude Bernard ( Site 0101)
Paris, Île-de-France Region, France
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City, Guatemala
MEDI-K ( Site 1053)
Guatemala City, Guatemala
CELAN,S.A ( Site 1052)
Guatemala City, Guatemala
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur, Malaysia
Asociación Civil Selva Amazónica ( Site 0556)
Iquitos, Loreto, Peru
Via Libre ( Site 0551)
Lima, Peru
Policlínico Socios en Salud ( Site 0557)
Lima, Peru
Investigaciones Medicas en Salud ( Site 0552)
Lima, Peru
Asociación Civil Impacta Salud y Educación ( Site 0553)
Lima, Peru
Universidad Nacional Mayor De San Marcos ( Site 0555)
Lima, Peru
LoveYourself Inc. ( Site 0705)
Mandaluyong, National Capital Region, Philippines
Philippine General Hospital ( Site 0700)
Manila, National Capital Region, Philippines
Asian Hospital and Medical Center ( Site 0704)
Muntinlupa, National Capital Region, Philippines
Foundation For Professional Development ( Site 0257)
King Williams Town, Eastern Cape, South Africa
Wits RHI Research Center ( Site 0251)
Johannesburg, Gauteng, South Africa
Setshaba Research Centre ( Site 0252)
Pretoria, Gauteng, South Africa
Perinatal HIV Research Unit (PHRU) ( Site 0253)
Soweto, Gauteng, South Africa
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
Durban, KwaZulu-Natal, South Africa
Desmond Tutu Health Foundation ( Site 0250)
Cape Town, Western Cape, South Africa
University Hospital Basel ( Site 1102)
Basel, Canton of Basel-City, Switzerland
Inselspital Bern ( Site 1103)
Bern, Canton of Bern, Switzerland
Checkpoint Zurich ( Site 1100)
Zurich, Switzerland
Chulalongkorn Hospital ( Site 0807)
Bangkok, Bangkok, Thailand
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
Bangkok, Bangkok, Thailand
Institute of HIV Research and Innovation ( Site 0810)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 0806)
Bangkok, Bangkok, Thailand
Research Institute for Health Sciences ( Site 0809)
Muang, Chiang Mai, Thailand
Hanoi Medical University Hospital ( Site 0851)
Hanoi, Hanoi, Vietnam
Thu Duc General Hospital ( Site 0881)
Ho Chi Minh City, Vietnam