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NCT07044297PHASE3RecruitingAccepts Healthy Volunteers

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

Merck Sharp & Dohme LLC

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

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 (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening * Weighs ≥35 kg Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has hypersensitivity or other contraindication to any component of the study interventions * Has evidence of acute or chronic hepatitis B infection * Has a history of malignancy within 5 years of screening except for adequately treated 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 product at any time * Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration * Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1 * Is expecting to donate eggs at any time during the study

Interventions

DRUG

MK-8527

DRUG

FTC/TDF

DRUG

Placebo to MK-8527

DRUG

Placebo to FTC/TDF

Interested in This Trial?

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Conditions

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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