A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Start Date
7/31/2025
Completion Date
7/22/2027
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 Criteria
Age Range: 16 years to No maximum
Interventions
MK-8527
FTC/TDF
Placebo to MK-8527
Placebo to FTC/TDF
Conditions
Locations
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham, Alabama 35222
United States
USA Health University Hospitals ( Site 0020)
Mobile, Alabama 36617
United States
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles, California 90035
United States
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco, California 94102
United States
Whitman-Walker Institute ( Site 0016)
Washington D.C., District of Columbia 20032
United States
University of Miami RAPID Research ( Site 0003)
Miami, Florida 33136
United States
Orlando Immunology Center ( Site 0021)
Orlando, Florida 32803
United States
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur, Georgia 30030
United States
University of Illinois Chicago ( Site 0027)
Chicago, Illinois 60612
United States
University Medical Center New Orleans ( Site 0024)
New Orleans, Louisiana 70112
United States
Open Arms Healthcare Center ( Site 0025)
Jackson, Mississippi 39202
United States
Rutgers New Jersey Medical School ( Site 0010)
Newark, New Jersey 07103
United States
Montefiore Medical Center ( Site 0017)
The Bronx, New York 10467
United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill, North Carolina 27514-7064
United States
Regional Center for Infectious Diseases ( Site 0018)
Greensboro, North Carolina 27401
United States
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia, Pennsylvania 19107
United States
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh, Pennsylvania 15213
United States
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia, South Carolina 29203
United States
St. Jude Children's Research Hospital ( Site 0026)
Memphis, Tennessee 38105
United States
Meharry Medical College ( Site 0013)
Nashville, Tennessee 37208
United States
Central Texas Clinical Research ( Site 0014)
Austin, Texas 78705
United States
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire, Texas 77401
United States
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle, Washington 98104
United States
Centro de Estudios Infectológicos S.A. ( Site 0357)
CABA, Buenos Aires C1002ABN
Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
CABA, Buenos Aires C1425AGC
Argentina
Fundación Huésped ( Site 0350)
CABA, Buenos Aires C1427CEA
Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Fundación IDEAA ( Site 0351)
Buenos Aires, C1405CKC
Argentina
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
Manaus, Amazonas 69040-000
Brazil
Obras Sociais Irma Dulce ( Site 0406)
Salvador, Estado de Bahia 41680-430
Brazil
School of Medicine Federal University of Minas Gerais ( Site 0417)
Belo Horizonte, Minas Gerais 30130-100
Brazil
Hospital Geral de Nova Iguacu ( Site 0411)
Nova Iguaçu, Rio de Janeiro 26030-380
Brazil
Ricardo Diaz Scientific Solutions ( Site 0402)
São Paulo, São Paulo 04030-030
Brazil
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
São Paulo, São Paulo 04121-000
Brazil
Hospital das Clinicas FMUSP ( Site 0401)
São Paulo, São Paulo 05403-000
Brazil
Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)
Rio de Janeiro, 21040-360
Brazil
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
Temuco, Araucania 4781151
Chile
Universidad San Sebastian - Providencia ( Site 0454)
Santiago, Region M. de Santiago 7500000
Chile
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
Santiago, Region M. de Santiago 8380420
Chile
IPS SURA San Diego ( Site 0500)
Medellín, Antioquia 50016
Colombia
Clinica de la Costa S.A.S. ( Site 0501)
Barranquilla, Atlántico 080020
Colombia
Hospital Universitario San Ignacio ( Site 0503)
Bogotá, Bogota D.C. 110231
Colombia
Fundación Valle del Lili ( Site 0502)
Cali, Valle del Cauca Department 760032
Colombia
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo, Nacional 10104
Dominican Republic
Endocardio ( Site 1003)
Santo Domingo, Nacional 10147
Dominican Republic
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)
Santo Domingo de Guzman, Santo Domingo Province 10306
Dominican Republic
Hopital Saint Louis ( Site 0100)
Paris, 75010
France
Hôpital Tenon ( Site 0102)
Paris, 75970
France
Hopital Bichat - Claude Bernard ( Site 0101)
Paris, Île-de-France Region 75018
France
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City, 01009
Guatemala
MEDI-K ( Site 1053)
Guatemala City, 01009
Guatemala
CELAN,S.A ( Site 1052)
Guatemala City, 01010
Guatemala
Partners for Health and Development in Africa ( Site 0201)
Nairobi, Nairobi City 00506
Kenya
Nyanza Reproductive Health Society ( Site 0200)
Kisumu, 40100
Kenya
Impact Research and Development Organisation (IRDO) ( Site 0202)
Kisumu, 40141
Kenya
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur, 50603
Malaysia
Asociación Civil Selva Amazónica ( Site 0556)
Iquitos, Loreto 16001
Peru
Via Libre ( Site 0551)
Lima, 15001
Peru
Policlínico Socios en Salud ( Site 0557)
Lima, 15024
Peru
Investigaciones Medicas en Salud ( Site 0552)
Lima, 15046
Peru
Asociación Civil Impacta Salud y Educación ( Site 0553)
Lima, 15063
Peru
Universidad Nacional Mayor De San Marcos ( Site 0555)
Lima, 15081
Peru
LoveYourself Inc. ( Site 0705)
Mandaluyong, National Capital Region 1552
Philippines
Philippine General Hospital ( Site 0700)
Manila, National Capital Region 1000
Philippines
Asian Hospital and Medical Center ( Site 0704)
Muntinlupa, National Capital Region 1780
Philippines
Foundation For Professional Development ( Site 0257)
King Williams Town, Eastern Cape 5660
South Africa
Wits RHI Research Center ( Site 0251)
Johannesburg, Gauteng 2001
South Africa
Setshaba Research Centre ( Site 0252)
Pretoria, Gauteng 0152
South Africa
Perinatal HIV Research Unit (PHRU) ( Site 0253)
Soweto, Gauteng 1864
South Africa
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
Durban, KwaZulu-Natal 4001
South Africa
Desmond Tutu Health Foundation ( Site 0250)
Cape Town, Western Cape 7925
South Africa
University Hospital Basel ( Site 1102)
Basel, Canton of Basel-City 4031
Switzerland
Inselspital Bern ( Site 1103)
Bern, Canton of Bern 3010
Switzerland
Checkpoint Zurich ( Site 1100)
Zurich, 8005
Switzerland
Chulalongkorn Hospital ( Site 0807)
Bangkok, Bangkok 10330
Thailand
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
Bangkok, Bangkok 10330
Thailand
Institute of HIV Research and Innovation ( Site 0810)
Bangkok, Bangkok 10330
Thailand
Faculty of Medicine Siriraj Hospital ( Site 0806)
Bangkok, Bangkok 10700
Thailand
Research Institute for Health Sciences ( Site 0809)
Muang, Chiang Mai 50200
Thailand
Hanoi Medical University Hospital ( Site 0851)
Hanoi, Hanoi 100000
Vietnam
Thu Duc General Hospital ( Site 0881)
Ho Chi Minh City, 700000
Vietnam