A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

Last updated: May 8, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Hiv/aids

Hiv (Pediatric)

Hiv Infections

Treatment

Placebo to FTC/TDF

Placebo to MK-8527

FTC/TDF

Clinical Study ID

NCT07044297
8527-011
MK-8527-011
U1111-1317-6239
2025-520610-58-00
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

Total Participants: 4390
Treatment Group(s): 4
Primary Treatment: Placebo to FTC/TDF
Phase: 3
Study Start date:
July 31, 2025
Estimated Completion Date:
July 22, 2027

Connect with a study center

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)

    CABA, Buenos Aires C1425AGC
    Argentina

    Active - Recruiting

  • Centro de Estudios Infectológicos S.A. ( Site 0357)

    CABA, Buenos Aires C1002ABN
    Argentina

    Active - Recruiting

  • Fundación Huésped ( Site 0350)

    CABA, Buenos Aires C1427CEA
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)

    Mar del Plata, Buenos Aires B7600FZO
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)

    Mar del Plata 3430863, Buenos Aires 3435907 B7600FZO
    Argentina

    Site Not Available

  • Fundación IDEAA ( Site 0351)

    Buenos Aires, C1405CKC
    Argentina

    Active - Recruiting

  • Fundación IDEAA ( Site 0351)

    Buenos Aires 3435910, C1405CKC
    Argentina

    Site Not Available

  • Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)

    Manaus, Amazonas 69040-000
    Brazil

    Active - Recruiting

  • Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)

    Manaus 3663517, Amazonas 3665361 69040-000
    Brazil

    Site Not Available

  • Obras Sociais Irma Dulce ( Site 0406)

    Salvador, Estado de Bahia 41680-430
    Brazil

    Active - Recruiting

  • Obras Sociais Irma Dulce ( Site 0406)

    Salvador 3450554, Estado de Bahia 3471168 41680-430
    Brazil

    Site Not Available

  • School of Medicine Federal University of Minas Gerais ( Site 0417)

    Belo Horizonte, Minas Gerais 30130-100
    Brazil

    Active - Recruiting

  • School of Medicine Federal University of Minas Gerais ( Site 0417)

    Belo Horizonte 3470127, Minas Gerais 3457153 30130-100
    Brazil

    Site Not Available

  • Hospital Geral de Nova Iguacu ( Site 0411)

    Nova Iguaçu, Rio de Janeiro 26030-380
    Brazil

    Active - Recruiting

  • Hospital Geral de Nova Iguacu ( Site 0411)

    Nova Iguaçu 3456160, Rio de Janeiro 3451189 26030-380
    Brazil

    Site Not Available

  • Centro de Referência e Treinamento DST/AIDS ( Site 0400)

    São Paulo, São Paulo 04121-000
    Brazil

    Active - Recruiting

  • Hospital das Clinicas FMUSP ( Site 0401)

    São Paulo, São Paulo 05403-000
    Brazil

    Active - Recruiting

  • Ricardo Diaz Scientific Solutions ( Site 0402)

    São Paulo, São Paulo 04030-030
    Brazil

    Active - Recruiting

  • Centro de Referência e Treinamento DST/AIDS ( Site 0400)

    São Paulo 3448439, São Paulo 3448433 04121-000
    Brazil

    Active - Recruiting

  • Hospital das Clinicas FMUSP ( Site 0401)

    São Paulo 3448439, São Paulo 3448433 05403-000
    Brazil

    Site Not Available

  • Ricardo Diaz Scientific Solutions ( Site 0402)

    São Paulo 3448439, São Paulo 3448433 04030-030
    Brazil

    Active - Recruiting

  • Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)

    Rio de Janeiro, 21040-360
    Brazil

    Active - Recruiting

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0451)

    Temuco, Araucania 4781151
    Chile

    Active - Recruiting

  • Universidad San Sebastian - Providencia ( Site 0454)

    Santiago, Region M. de Santiago 7500000
    Chile

    Active - Recruiting

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)

    Santiago, Region M. de Santiago 8380420
    Chile

    Active - Recruiting

  • Universidad San Sebastian - Providencia ( Site 0454)

    Santiago 3871336, Region M. de Santiago 7500000
    Chile

    Site Not Available

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)

    Santiago 3871336, Region M. de Santiago 8380420
    Chile

    Active - Recruiting

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0451)

    Temuco 3870011, Región de la Araucanía 3899463 4781151
    Chile

    Site Not Available

  • IPS SURA San Diego ( Site 0500)

    Medellín, Antioquia 50016
    Colombia

    Active - Recruiting

  • IPS SURA San Diego ( Site 0500)

    Medellín 3674962, Antioquia 3689815 50016
    Colombia

    Site Not Available

  • Clinica de la Costa S.A.S. ( Site 0501)

    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

  • Clinica de la Costa S.A.S. ( Site 0501)

    Barranquilla 3689147, Atlántico 3689436 080020
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio ( Site 0503)

    Bogotá, Bogota D.C. 110231
    Colombia

    Active - Recruiting

  • Hospital Universitario San Ignacio ( Site 0503)

    Bogotá 3688689, Bogota D.C. 3688685 110231
    Colombia

    Site Not Available

  • Fundación Valle del Lili ( Site 0502)

    Cali, Valle del Cauca Department 760036
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 0502)

    Cali 3687925, Valle del Cauca Department 3666313 760036
    Colombia

    Site Not Available

  • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)

    Santo Domingo, Nacional 10104
    Dominican Republic

    Active - Recruiting

  • Endocardio ( Site 1003)

    Santo Domingo, Nacional 10147
    Dominican Republic

    Active - Recruiting

  • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)

    Santo Domingo 3492908, Nacional 3496024 10104
    Dominican Republic

    Site Not Available

  • Endocardio ( Site 1003)

    Santo Domingo 3492908, Nacional 3496024 10147
    Dominican Republic

    Active - Recruiting

  • Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)

    Santo Domingo de Guzman, Santo Domingo Province 10306
    Dominican Republic

    Active - Recruiting

  • Hopital Bichat - Claude Bernard ( Site 0101)

    Paris, Île-de-France Region 75018
    France

    Active - Recruiting

  • Hopital Bichat - Claude Bernard ( Site 0101)

    Paris 2988507, Île-de-France Region 3012874 75018
    France

    Site Not Available

  • Hopital Saint Louis ( Site 0100)

    Paris, 75010
    France

    Active - Recruiting

  • Hôpital Tenon ( Site 0102)

    Paris, 75970
    France

    Active - Recruiting

  • Hopital Saint Louis ( Site 0100)

    Paris 2988507, 75010
    France

    Active - Recruiting

  • Hôpital Tenon ( Site 0102)

    Paris 2988507, 75020
    France

    Active - Recruiting

  • CELAN,S.A ( Site 1052)

    Guatemala City, 01010
    Guatemala

    Active - Recruiting

  • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)

    Guatemala City, 01009
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 1053)

    Guatemala City, 01009
    Guatemala

    Active - Recruiting

  • CELAN,S.A ( Site 1052)

    Guatemala City 3598132, 01010
    Guatemala

    Site Not Available

  • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)

    Guatemala City 3598132, 01009
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 1053)

    Guatemala City 3598132, 01009
    Guatemala

    Active - Recruiting

  • Partners for Health and Development in Africa ( Site 0201)

    Nairobi, Nairobi City 00506
    Kenya

    Active - Recruiting

  • Impact Research and Development Organisation (IRDO) ( Site 0202)

    Kisumu, 40141
    Kenya

    Active - Recruiting

  • Kargeno Research & Policy Hub ( Site 0200)

    Kisumu, 40123
    Kenya

    Active - Recruiting

  • Universiti Malaya Medical Centre ( Site 0651)

    Kuala Lumpur, 50603
    Malaysia

    Active - Recruiting

  • Universiti Malaya Medical Centre ( Site 0651)

    Kuala Lumpur 1735161, 50603
    Malaysia

    Site Not Available

  • Asociación Civil Selva Amazónica ( Site 0556)

    Iquitos, Loreto 16001
    Peru

    Active - Recruiting

  • Asociación Civil Impacta Salud y Educación ( Site 0553)

    Lima, 15063
    Peru

    Active - Recruiting

  • Investigaciones Medicas en Salud ( Site 0552)

    Lima, 15046
    Peru

    Active - Recruiting

  • Policlínico Socios en Salud ( Site 0557)

    Lima, 15024
    Peru

    Active - Recruiting

  • Universidad Nacional Mayor De San Marcos ( Site 0555)

    Lima, 15081
    Peru

    Active - Recruiting

  • Via Libre ( Site 0551)

    Lima, 15001
    Peru

    Active - Recruiting

  • Investigaciones Medicas en Salud ( Site 0552)

    Lima 3936456, 15046
    Peru

    Site Not Available

  • Policlínico Socios en Salud ( Site 0557)

    Lima 3936456, 15024
    Peru

    Active - Recruiting

  • Via Libre ( Site 0551)

    Lima 3936456, 15001
    Peru

    Active - Recruiting

  • LoveYourself Inc. ( Site 0705)

    Mandaluyong, National Capital Region 1552
    Philippines

    Active - Recruiting

  • Philippine General Hospital ( Site 0700)

    Manila, National Capital Region 1000
    Philippines

    Active - Recruiting

  • Asian Hospital and Medical Center ( Site 0704)

    Muntinlupa, National Capital Region 1780
    Philippines

    Active - Recruiting

  • Foundation For Professional Development ( Site 0257)

    King Williams Town, Eastern Cape 5660
    South Africa

    Active - Recruiting

  • Wits RHI Research Center ( Site 0251)

    Johannesburg, Gauteng 2001
    South Africa

    Active - Recruiting

  • Setshaba Research Centre ( Site 0252)

    Pretoria, Gauteng 0152
    South Africa

    Active - Recruiting

  • Perinatal HIV Research Unit (PHRU) ( Site 0253)

    Soweto, Gauteng 1864
    South Africa

    Active - Recruiting

  • Wits RHI Research Center ( Site 0251)

    Johannesburg 993800, Gauteng 1085594 2001
    South Africa

    Site Not Available

  • Setshaba Research Centre ( Site 0252)

    Pretoria 964137, Gauteng 1085594 0152
    South Africa

    Site Not Available

  • Perinatal HIV Research Unit (PHRU) ( Site 0253)

    Soweto 953781, Gauteng 1085594 1864
    South Africa

    Site Not Available

  • Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)

    Durban, KwaZulu-Natal 4001
    South Africa

    Active - Recruiting

  • Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)

    Durban 1007311, KwaZulu-Natal 972062 4001
    South Africa

    Site Not Available

  • Desmond Tutu Health Foundation ( Site 0250)

    Cape Town, Western Cape 7925
    South Africa

    Active - Recruiting

  • Desmond Tutu Health Foundation ( Site 0250)

    Cape Town 3369157, Western Cape 1085599 7925
    South Africa

    Site Not Available

  • University Hospital Basel ( Site 1102)

    Basel, Canton of Basel-City 4031
    Switzerland

    Active - Recruiting

  • University Hospital Basel ( Site 1102)

    Basel 2661604, Canton of Basel-City 2661602 4031
    Switzerland

    Site Not Available

  • Inselspital Bern ( Site 1103)

    Bern, Canton of Bern 3010
    Switzerland

    Active - Recruiting

  • Inselspital Bern ( Site 1103)

    Bern 2661552, Canton of Bern 2661551 3010
    Switzerland

    Site Not Available

  • Checkpoint Zurich ( Site 1100)

    Zurich, 8005
    Switzerland

    Active - Recruiting

  • Checkpoint Zurich ( Site 1100)

    Zurich 2657896, 8005
    Switzerland

    Site Not Available

  • Chulalongkorn Hospital ( Site 0807)

    Bangkok, Bangkok 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 0806)

    Bangkok, Bangkok 10700
    Thailand

    Active - Recruiting

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)

    Bangkok, Bangkok 10330
    Thailand

    Active - Recruiting

  • Institute of HIV Research and Innovation ( Site 0810)

    Bangkok, Bangkok 10330
    Thailand

    Active - Recruiting

  • Chulalongkorn Hospital ( Site 0807)

    Bangkok 1609350, Bangkok 1609348 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 0806)

    Bangkok 1609350, Bangkok 1609348 10700
    Thailand

    Active - Recruiting

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)

    Bangkok 1609350, Bangkok 1609348 10330
    Thailand

    Active - Recruiting

  • Institute of HIV Research and Innovation ( Site 0810)

    Bangkok 1609350, Bangkok 1609348 10330
    Thailand

    Site Not Available

  • Research Institute for Health Sciences ( Site 0809)

    Muang, Chiang Mai 50200
    Thailand

    Active - Recruiting

  • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)

    Birmingham, Alabama 35222
    United States

    Active - Recruiting

  • USA Health University Hospitals ( Site 0020)

    Mobile, Alabama 36617
    United States

    Active - Recruiting

  • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)

    Birmingham 4049979, Alabama 4829764 35222
    United States

    Site Not Available

  • USA Health University Hospitals ( Site 0020)

    Mobile 4076598, Alabama 4829764 36617
    United States

    Site Not Available

  • UCLA Center for Clinical AIDS Research and Education ( Site 0004)

    Los Angeles, California 90035
    United States

    Active - Recruiting

  • Bridge HIV - San Francisco Department of Public Health

    San Francisco, California 94102
    United States

    Site Not Available

  • Bridge HIV - San Francisco Department of Public Health ( Site 0001)

    San Francisco, California 94102
    United States

    Active - Recruiting

  • UCLA Center for Clinical AIDS Research and Education ( Site 0004)

    Los Angeles 5368361, California 5332921 90035
    United States

    Site Not Available

  • Bridge HIV - San Francisco Department of Public Health ( Site 0001)

    San Francisco 5391959, California 5332921 94102
    United States

    Site Not Available

  • Whitman-Walker Institute ( Site 0016)

    Washington D.C., District of Columbia 20032
    United States

    Active - Recruiting

  • Whitman-Walker Institute ( Site 0016)

    Washington D.C. 4140963, District of Columbia 4138106 20032
    United States

    Site Not Available

  • University of Miami RAPID Research ( Site 0003)

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Orlando Immunology Center ( Site 0021)

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • University of Miami RAPID Research ( Site 0003)

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Orlando Immunology Center ( Site 0021)

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Hope Clinic of the Emory Vaccine Center ( Site 0009)

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Hope Clinic of the Emory Vaccine Center ( Site 0009)

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • University of Illinois Chicago ( Site 0027)

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Illinois Chicago ( Site 0027)

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • University Medical Center New Orleans ( Site 0024)

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • University Medical Center New Orleans ( Site 0024)

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Site Not Available

  • Open Arms Healthcare Center ( Site 0025)

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

  • Open Arms Healthcare Center ( Site 0025)

    Jackson 4431410, Mississippi 4436296 39202
    United States

    Site Not Available

  • Rutgers New Jersey Medical School ( Site 0010)

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • Rutgers New Jersey Medical School ( Site 0010)

    Newark 5101798, New Jersey 5101760 07103
    United States

    Site Not Available

  • Montefiore Medical Center ( Site 0017)

    The Bronx, New York 10467
    United States

    Active - Recruiting

  • Montefiore Medical Center ( Site 0017)

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)

    Chapel Hill, North Carolina 27514-7064
    United States

    Active - Recruiting

  • Regional Center for Infectious Diseases

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Regional Center for Infectious Diseases ( Site 0018)

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)

    Chapel Hill 4460162, North Carolina 4482348 27514-7064
    United States

    Site Not Available

  • Regional Center for Infectious Diseases ( Site 0018)

    Greensboro 4469146, North Carolina 4482348 27401
    United States

    Site Not Available

  • Philadelphia Fight Community Health Centers ( Site 0011)

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Philadelphia Fight Community Health Centers ( Site 0011)

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Site Not Available

  • St. Jude Children's Research Hospital ( Site 0026)

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • Meharry Medical College ( Site 0013)

    Nashville, Tennessee 37208
    United States

    Active - Recruiting

  • St. Jude Children's Research Hospital ( Site 0026)

    Memphis 4641239, Tennessee 4662168 38105
    United States

    Site Not Available

  • Meharry Medical College ( Site 0013)

    Nashville 4644585, Tennessee 4662168 37208
    United States

    Site Not Available

  • Central Texas Clinical Research ( Site 0014)

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Saint Hope Foundation, Inc

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Saint Hope Foundation, Inc. ( Site 0015)

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Central Texas Clinical Research ( Site 0014)

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Saint Hope Foundation, Inc. ( Site 0015)

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • Hanoi Medical University Hospital ( Site 0851)

    Hanoi, Hanoi 100000
    Vietnam

    Active - Recruiting

  • Thu Duc General Hospital ( Site 0881)

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

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