Phase
Condition
Hiv/aids
Hiv (Pediatric)
Hiv Infections
Treatment
Placebo to FTC/TDF
Placebo to MK-8527
FTC/TDF
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 C1425AGC
ArgentinaActive - Recruiting
Centro de Estudios Infectológicos S.A. ( Site 0357)
CABA, Buenos Aires C1002ABN
ArgentinaActive - Recruiting
Fundación Huésped ( Site 0350)
CABA, Buenos Aires C1427CEA
ArgentinaActive - Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
Mar del Plata, Buenos Aires B7600FZO
ArgentinaActive - Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
Mar del Plata 3430863, Buenos Aires 3435907 B7600FZO
ArgentinaSite Not Available
Fundación IDEAA ( Site 0351)
Buenos Aires, C1405CKC
ArgentinaActive - Recruiting
Fundación IDEAA ( Site 0351)
Buenos Aires 3435910, C1405CKC
ArgentinaSite Not Available
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
Manaus, Amazonas 69040-000
BrazilActive - Recruiting
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
Manaus 3663517, Amazonas 3665361 69040-000
BrazilSite Not Available
Obras Sociais Irma Dulce ( Site 0406)
Salvador, Estado de Bahia 41680-430
BrazilActive - Recruiting
Obras Sociais Irma Dulce ( Site 0406)
Salvador 3450554, Estado de Bahia 3471168 41680-430
BrazilSite Not Available
School of Medicine Federal University of Minas Gerais ( Site 0417)
Belo Horizonte, Minas Gerais 30130-100
BrazilActive - Recruiting
School of Medicine Federal University of Minas Gerais ( Site 0417)
Belo Horizonte 3470127, Minas Gerais 3457153 30130-100
BrazilSite Not Available
Hospital Geral de Nova Iguacu ( Site 0411)
Nova Iguaçu, Rio de Janeiro 26030-380
BrazilActive - Recruiting
Hospital Geral de Nova Iguacu ( Site 0411)
Nova Iguaçu 3456160, Rio de Janeiro 3451189 26030-380
BrazilSite Not Available
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
São Paulo, São Paulo 04121-000
BrazilActive - Recruiting
Hospital das Clinicas FMUSP ( Site 0401)
São Paulo, São Paulo 05403-000
BrazilActive - Recruiting
Ricardo Diaz Scientific Solutions ( Site 0402)
São Paulo, São Paulo 04030-030
BrazilActive - Recruiting
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
São Paulo 3448439, São Paulo 3448433 04121-000
BrazilActive - Recruiting
Hospital das Clinicas FMUSP ( Site 0401)
São Paulo 3448439, São Paulo 3448433 05403-000
BrazilSite Not Available
Ricardo Diaz Scientific Solutions ( Site 0402)
São Paulo 3448439, São Paulo 3448433 04030-030
BrazilActive - Recruiting
Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)
Rio de Janeiro, 21040-360
BrazilActive - Recruiting
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
Temuco, Araucania 4781151
ChileActive - Recruiting
Universidad San Sebastian - Providencia ( Site 0454)
Santiago, Region M. de Santiago 7500000
ChileActive - Recruiting
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
Santiago, Region M. de Santiago 8380420
ChileActive - Recruiting
Universidad San Sebastian - Providencia ( Site 0454)
Santiago 3871336, Region M. de Santiago 7500000
ChileSite Not Available
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
Santiago 3871336, Region M. de Santiago 8380420
ChileActive - Recruiting
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
Temuco 3870011, Región de la Araucanía 3899463 4781151
ChileSite Not Available
IPS SURA San Diego ( Site 0500)
Medellín, Antioquia 50016
ColombiaActive - Recruiting
IPS SURA San Diego ( Site 0500)
Medellín 3674962, Antioquia 3689815 50016
ColombiaSite Not Available
Clinica de la Costa S.A.S. ( Site 0501)
Barranquilla, Atlántico 080020
ColombiaActive - Recruiting
Clinica de la Costa S.A.S. ( Site 0501)
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaSite Not Available
Hospital Universitario San Ignacio ( Site 0503)
Bogotá, Bogota D.C. 110231
ColombiaActive - Recruiting
Hospital Universitario San Ignacio ( Site 0503)
Bogotá 3688689, Bogota D.C. 3688685 110231
ColombiaSite Not Available
Fundación Valle del Lili ( Site 0502)
Cali, Valle del Cauca Department 760036
ColombiaActive - Recruiting
Fundación Valle del Lili ( Site 0502)
Cali 3687925, Valle del Cauca Department 3666313 760036
ColombiaSite Not Available
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo, Nacional 10104
Dominican RepublicActive - Recruiting
Endocardio ( Site 1003)
Santo Domingo, Nacional 10147
Dominican RepublicActive - Recruiting
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo 3492908, Nacional 3496024 10104
Dominican RepublicSite Not Available
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 10306
Dominican RepublicActive - Recruiting
Hopital Bichat - Claude Bernard ( Site 0101)
Paris, Île-de-France Region 75018
FranceActive - Recruiting
Hopital Bichat - Claude Bernard ( Site 0101)
Paris 2988507, Île-de-France Region 3012874 75018
FranceSite Not Available
Hopital Saint Louis ( Site 0100)
Paris, 75010
FranceActive - Recruiting
Hôpital Tenon ( Site 0102)
Paris, 75970
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, 01010
GuatemalaActive - Recruiting
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City, 01009
GuatemalaActive - Recruiting
MEDI-K ( Site 1053)
Guatemala City, 01009
GuatemalaActive - Recruiting
CELAN,S.A ( Site 1052)
Guatemala City 3598132, 01010
GuatemalaSite Not Available
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
Partners for Health and Development in Africa ( Site 0201)
Nairobi, Nairobi City 00506
KenyaActive - Recruiting
Impact Research and Development Organisation (IRDO) ( Site 0202)
Kisumu, 40141
KenyaActive - Recruiting
Kargeno Research & Policy Hub ( Site 0200)
Kisumu, 40123
KenyaActive - Recruiting
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur, 50603
MalaysiaActive - Recruiting
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur 1735161, 50603
MalaysiaSite Not Available
Asociación Civil Selva Amazónica ( Site 0556)
Iquitos, Loreto 16001
PeruActive - Recruiting
Asociación Civil Impacta Salud y Educación ( Site 0553)
Lima, 15063
PeruActive - Recruiting
Investigaciones Medicas en Salud ( Site 0552)
Lima, 15046
PeruActive - Recruiting
Policlínico Socios en Salud ( Site 0557)
Lima, 15024
PeruActive - Recruiting
Universidad Nacional Mayor De San Marcos ( Site 0555)
Lima, 15081
PeruActive - Recruiting
Via Libre ( Site 0551)
Lima, 15001
PeruActive - Recruiting
Investigaciones Medicas en Salud ( Site 0552)
Lima 3936456, 15046
PeruSite Not Available
Policlínico Socios en Salud ( Site 0557)
Lima 3936456, 15024
PeruActive - Recruiting
Via Libre ( Site 0551)
Lima 3936456, 15001
PeruActive - Recruiting
LoveYourself Inc. ( Site 0705)
Mandaluyong, National Capital Region 1552
PhilippinesActive - Recruiting
Philippine General Hospital ( Site 0700)
Manila, National Capital Region 1000
PhilippinesActive - Recruiting
Asian Hospital and Medical Center ( Site 0704)
Muntinlupa, National Capital Region 1780
PhilippinesActive - Recruiting
Foundation For Professional Development ( Site 0257)
King Williams Town, Eastern Cape 5660
South AfricaActive - Recruiting
Wits RHI Research Center ( Site 0251)
Johannesburg, Gauteng 2001
South AfricaActive - Recruiting
Setshaba Research Centre ( Site 0252)
Pretoria, Gauteng 0152
South AfricaActive - Recruiting
Perinatal HIV Research Unit (PHRU) ( Site 0253)
Soweto, Gauteng 1864
South AfricaActive - Recruiting
Wits RHI Research Center ( Site 0251)
Johannesburg 993800, Gauteng 1085594 2001
South AfricaSite Not Available
Setshaba Research Centre ( Site 0252)
Pretoria 964137, Gauteng 1085594 0152
South AfricaSite Not Available
Perinatal HIV Research Unit (PHRU) ( Site 0253)
Soweto 953781, Gauteng 1085594 1864
South AfricaSite Not Available
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
Durban, KwaZulu-Natal 4001
South AfricaActive - Recruiting
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
Durban 1007311, KwaZulu-Natal 972062 4001
South AfricaSite Not Available
Desmond Tutu Health Foundation ( Site 0250)
Cape Town, Western Cape 7925
South AfricaActive - Recruiting
Desmond Tutu Health Foundation ( Site 0250)
Cape Town 3369157, Western Cape 1085599 7925
South AfricaSite Not Available
University Hospital Basel ( Site 1102)
Basel, Canton of Basel-City 4031
SwitzerlandActive - Recruiting
University Hospital Basel ( Site 1102)
Basel 2661604, Canton of Basel-City 2661602 4031
SwitzerlandSite Not Available
Inselspital Bern ( Site 1103)
Bern, Canton of Bern 3010
SwitzerlandActive - Recruiting
Inselspital Bern ( Site 1103)
Bern 2661552, Canton of Bern 2661551 3010
SwitzerlandSite Not Available
Checkpoint Zurich ( Site 1100)
Zurich, 8005
SwitzerlandActive - Recruiting
Checkpoint Zurich ( Site 1100)
Zurich 2657896, 8005
SwitzerlandSite Not Available
Chulalongkorn Hospital ( Site 0807)
Bangkok, Bangkok 10330
ThailandActive - Recruiting
Faculty of Medicine Siriraj Hospital ( Site 0806)
Bangkok, Bangkok 10700
ThailandActive - Recruiting
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
Bangkok, Bangkok 10330
ThailandActive - Recruiting
Institute of HIV Research and Innovation ( Site 0810)
Bangkok, Bangkok 10330
ThailandActive - Recruiting
Chulalongkorn Hospital ( Site 0807)
Bangkok 1609350, Bangkok 1609348 10330
ThailandActive - Recruiting
Faculty of Medicine Siriraj Hospital ( Site 0806)
Bangkok 1609350, Bangkok 1609348 10700
ThailandActive - Recruiting
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
Bangkok 1609350, Bangkok 1609348 10330
ThailandActive - Recruiting
Institute of HIV Research and Innovation ( Site 0810)
Bangkok 1609350, Bangkok 1609348 10330
ThailandSite Not Available
Research Institute for Health Sciences ( Site 0809)
Muang, Chiang Mai 50200
ThailandActive - Recruiting
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham, Alabama 35222
United StatesActive - Recruiting
USA Health University Hospitals ( Site 0020)
Mobile, Alabama 36617
United StatesActive - Recruiting
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham 4049979, Alabama 4829764 35222
United StatesSite Not Available
USA Health University Hospitals ( Site 0020)
Mobile 4076598, Alabama 4829764 36617
United StatesSite Not Available
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles, California 90035
United StatesActive - Recruiting
Bridge HIV - San Francisco Department of Public Health
San Francisco, California 94102
United StatesSite Not Available
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco, California 94102
United StatesActive - Recruiting
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles 5368361, California 5332921 90035
United StatesSite Not Available
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco 5391959, California 5332921 94102
United StatesSite Not Available
Whitman-Walker Institute ( Site 0016)
Washington D.C., District of Columbia 20032
United StatesActive - Recruiting
Whitman-Walker Institute ( Site 0016)
Washington D.C. 4140963, District of Columbia 4138106 20032
United StatesSite Not Available
University of Miami RAPID Research ( Site 0003)
Miami, Florida 33136
United StatesActive - Recruiting
Orlando Immunology Center ( Site 0021)
Orlando, Florida 32803
United StatesActive - Recruiting
University of Miami RAPID Research ( Site 0003)
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Orlando Immunology Center ( Site 0021)
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur, Georgia 30030
United StatesActive - Recruiting
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
University of Illinois Chicago ( Site 0027)
Chicago, Illinois 60612
United StatesActive - Recruiting
University of Illinois Chicago ( Site 0027)
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University Medical Center New Orleans ( Site 0024)
New Orleans, Louisiana 70112
United StatesActive - Recruiting
University Medical Center New Orleans ( Site 0024)
New Orleans 4335045, Louisiana 4331987 70112
United StatesSite Not Available
Open Arms Healthcare Center ( Site 0025)
Jackson, Mississippi 39202
United StatesActive - Recruiting
Open Arms Healthcare Center ( Site 0025)
Jackson 4431410, Mississippi 4436296 39202
United StatesSite Not Available
Rutgers New Jersey Medical School ( Site 0010)
Newark, New Jersey 07103
United StatesActive - Recruiting
Rutgers New Jersey Medical School ( Site 0010)
Newark 5101798, New Jersey 5101760 07103
United StatesSite Not Available
Montefiore Medical Center ( Site 0017)
The Bronx, New York 10467
United StatesActive - Recruiting
Montefiore Medical Center ( Site 0017)
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill, North Carolina 27514-7064
United StatesActive - Recruiting
Regional Center for Infectious Diseases
Greensboro, North Carolina 27401
United StatesSite Not Available
Regional Center for Infectious Diseases ( Site 0018)
Greensboro, North Carolina 27401
United StatesActive - Recruiting
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill 4460162, North Carolina 4482348 27514-7064
United StatesSite Not Available
Regional Center for Infectious Diseases ( Site 0018)
Greensboro 4469146, North Carolina 4482348 27401
United StatesSite Not Available
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia, South Carolina 29203
United StatesActive - Recruiting
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia 4575352, South Carolina 4597040 29203
United StatesSite Not Available
St. Jude Children's Research Hospital ( Site 0026)
Memphis, Tennessee 38105
United StatesActive - Recruiting
Meharry Medical College ( Site 0013)
Nashville, Tennessee 37208
United StatesActive - Recruiting
St. Jude Children's Research Hospital ( Site 0026)
Memphis 4641239, Tennessee 4662168 38105
United StatesSite Not Available
Meharry Medical College ( Site 0013)
Nashville 4644585, Tennessee 4662168 37208
United StatesSite Not Available
Central Texas Clinical Research ( Site 0014)
Austin, Texas 78705
United StatesActive - Recruiting
Saint Hope Foundation, Inc
Bellaire, Texas 77401
United StatesSite Not Available
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire, Texas 77401
United StatesActive - Recruiting
Central Texas Clinical Research ( Site 0014)
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle, Washington 98104
United StatesActive - Recruiting
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available
Hanoi Medical University Hospital ( Site 0851)
Hanoi, Hanoi 100000
VietnamActive - Recruiting
Thu Duc General Hospital ( Site 0881)
Ho Chi Minh City, 700000
VietnamActive - Recruiting

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