Phase
Condition
Hiv/aids
Hiv (Pediatric)
Sexually Transmitted Diseases (Stds)
Treatment
Placebo to FTC/TDF
MK-8527
Placebo to MK-8527
Clinical Study ID
Ages > 16 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 (notincluding sex occurring in a mutually monogamous relationship) and has at least 1 ofthe following: receptive anal sex with 2 or more partners in the 3 months prior toscreening (regardless of condom use), rectal or urethral gonorrhea or chlamydia orincident syphilis in the 6 months prior to screening, or any self-reported stimulantdrug use with sex in the 3 months prior to screening
Weighs ≥35 kg
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has hypersensitivity or other contraindication to any component of the studyinterventions
Has evidence of acute or chronic hepatitis B infection
Has a history of malignancy within 5 years of screening except for adequatelytreated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention productat any time
Is receiving or is anticipated to require any prohibited therapies from 30 daysprior to Day 1 through the study duration
Has received an HIV vaccine at any time (ie, through past participation in aninvestigational clinical study) or monoclonal antibodies to HIV within 12 monthsbefore Day 1
Is expecting to donate eggs at any time during the study
Study Design
Connect with a study center
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
CABA, Buenos Aires 3435907 C1425AGC
ArgentinaActive - Recruiting
Centro de Estudios Infectológicos S.A. ( Site 0357)
CABA, Buenos Aires 3435907 C1002ABN
ArgentinaActive - Recruiting
Fundación Huésped ( Site 0350)
CABA, Buenos Aires 3435907 C1427CEA
ArgentinaActive - Recruiting
Fundación IDEAA ( Site 0351)
Buenos Aires 3435910, C1405CKC
ArgentinaActive - Recruiting
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo 3492908, Nacional 3496024 10104
Dominican RepublicActive - Recruiting
Endocardio ( Site 1003)
Santo Domingo 3492908, Nacional 3496024 10147
Dominican RepublicActive - Recruiting
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)
Santo Domingo de Guzman, Santo Domingo Province 6201373 10305
Dominican RepublicActive - Recruiting
Hopital Bichat - Claude Bernard ( Site 0101)
Paris 2988507, Île-de-France Region 3012874 75018
FranceActive - Recruiting
Hopital Saint Louis ( Site 0100)
Paris 2988507, 75010
FranceActive - Recruiting
Hôpital Tenon ( Site 0102)
Paris 2988507, 75020
FranceActive - Recruiting
CELAN,S.A ( Site 1052)
Guatemala City 3598132, 01010
GuatemalaActive - Recruiting
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City 3598132, 01009
GuatemalaActive - Recruiting
MEDI-K ( Site 1053)
Guatemala City 3598132, 01009
GuatemalaActive - Recruiting
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur 1735161, 50603
MalaysiaActive - Recruiting
Foundation For Professional Development ( Site 0257)
King Williams Town, Eastern Cape 1085593 5660
South AfricaActive - Recruiting
Wits RHI Research Center ( Site 0251)
Johannesburg 993800, Gauteng 1085594 2001
South AfricaActive - Recruiting
Setshaba Research Centre ( Site 0252)
Pretoria 964137, Gauteng 1085594 0152
South AfricaActive - Recruiting
Perinatal HIV Research Unit (PHRU) ( Site 0253)
Soweto 953781, Gauteng 1085594 1864
South AfricaActive - Recruiting
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
Durban 1007311, KwaZulu-Natal 972062 4001
South AfricaActive - Recruiting
Desmond Tutu Health Foundation ( Site 0250)
Cape Town 3369157, Western Cape 1085599 7925
South AfricaActive - Recruiting
University Hospital Basel ( Site 1102)
Basel, Basel-Landschaft 2661603 4031
SwitzerlandSite Not Available
University Hospital Basel ( Site 1102)
Basel 2661604, Canton of Basel-City 2661602 4031
SwitzerlandActive - Recruiting
Inselspital Bern ( Site 1103)
Bern 2661552, Canton of Bern 2661551 3010
SwitzerlandActive - Recruiting
Checkpoint Zurich ( Site 1100)
Zurich 2657896, 8005
SwitzerlandActive - Recruiting
Faculty of Medicine Siriraj Hospital ( Site 0806)
Bangkok 1609350, Bangkok 1609348 10700
ThailandActive - Recruiting
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham 4049979, Alabama 4829764 35222
United StatesActive - Recruiting
USA Health University Hospitals ( Site 0020)
Mobile 4076598, Alabama 4829764 36617
United StatesActive - Recruiting
Bridge HIV - San Francisco Department of Public Health
San Francisco, California 94102
United StatesSite Not Available
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles 5368361, California 5332921 90035
United StatesActive - Recruiting
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco 5391959, California 5332921 94102
United StatesActive - Recruiting
Whitman-Walker Institute ( Site 0016)
Washington D.C. 4140963, District of Columbia 4138106 20032
United StatesActive - Recruiting
University of Miami RAPID Research ( Site 0003)
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Orlando Immunology Center ( Site 0021)
Orlando 4167147, Florida 4155751 32803
United StatesActive - Recruiting
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur 4191124, Georgia 4197000 30030
United StatesActive - Recruiting
University of Illinois Chicago ( Site 0027)
Chicago 4887398, Illinois 4896861 60612
United StatesActive - Recruiting
University Medical Center New Orleans ( Site 0024)
New Orleans 4335045, Louisiana 4331987 70112
United StatesActive - Recruiting
Open Arms Healthcare Center ( Site 0025)
Jackson 4431410, Mississippi 4436296 39202
United StatesActive - Recruiting
Rutgers New Jersey Medical School ( Site 0010)
Newark 5101798, New Jersey 5101760 07103
United StatesActive - Recruiting
Montefiore Medical Center ( Site 0017)
The Bronx 5110266, New York 5128638 10467
United StatesActive - Recruiting
Regional Center for Infectious Diseases
Greensboro, North Carolina 27401
United StatesSite Not Available
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill 4460162, North Carolina 4482348 27514-7064
United StatesActive - Recruiting
Regional Center for Infectious Diseases ( Site 0018)
Greensboro 4469146, North Carolina 4482348 27401
United StatesActive - Recruiting
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia 4575352, South Carolina 4597040 29203
United StatesActive - Recruiting
Meharry Medical College ( Site 0013)
Nashville 4644585, Tennessee 4662168 37208
United StatesActive - Recruiting
Saint Hope Foundation, Inc
Bellaire, Texas 77401
United StatesSite Not Available
Central Texas Clinical Research ( Site 0014)
Austin 4671654, Texas 4736286 78705
United StatesActive - Recruiting
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire 4673353, Texas 4736286 77401
United StatesActive - Recruiting
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting
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