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

NCT07044297 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 8527-011MK-8527-0112025-520610-58-00U1111-1317-6239
• Study Type: interventional
• Target: 4,390
• Locations: 15 countries
• Sites: 78

Brief 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

Conditions

Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection

  The number of participants with adjudicated HIV-1 infection will be determined.

  Up to approximately 2 years

• Number of Participants Who Experience At Least One Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be reported.

  Up to approximately 2 years

• Number of Participants Who Discontinue Study Intervention Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be reported.

  Up to approximately 2 years

Study Arms (2)

MK-8527

EXPERIMENTAL

Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to FTC/TDF once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Drug: MK-8527; Drug: FTC/TDF; Drug: Placebo to FTC/TDF

FTC/TDF

ACTIVE COMPARATOR

Participants will receive 200 mg FTC/245 mg TDF QD and placebo to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Drug: FTC/TDF; Drug: Placebo to MK-8527

Interventions

MK-8527 DRUG

Oral tablet

MK-8527

FTC/TDF DRUG

Oral tablet

Also known as: Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate

FTC/TDF; MK-8527

Placebo to MK-8527 DRUG

Placebo tablet matched to MK-8527

FTC/TDF

Placebo to FTC/TDF DRUG

Placebo tablet matched to FTC/TDF

MK-8527

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (78)

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

Birmingham, Alabama, 35222, United States

RECRUITING

USA Health University Hospitals ( Site 0020)

Mobile, Alabama, 36617, United States

RECRUITING

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

Los Angeles, California, 90035, United States

RECRUITING

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

San Francisco, California, 94102, United States

RECRUITING

Whitman-Walker Institute ( Site 0016)

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

RECRUITING

University of Miami RAPID Research ( Site 0003)

Miami, Florida, 33136, United States

RECRUITING

Orlando Immunology Center ( Site 0021)

Orlando, Florida, 32803, United States

RECRUITING

Hope Clinic of the Emory Vaccine Center ( Site 0009)

Decatur, Georgia, 30030, United States

RECRUITING

University of Illinois Chicago ( Site 0027)

Chicago, Illinois, 60612, United States

RECRUITING

University Medical Center New Orleans ( Site 0024)

New Orleans, Louisiana, 70112, United States

RECRUITING

Open Arms Healthcare Center ( Site 0025)

Jackson, Mississippi, 39202, United States

RECRUITING

Rutgers New Jersey Medical School ( Site 0010)

Newark, New Jersey, 07103, United States

RECRUITING

Montefiore Medical Center ( Site 0017)

The Bronx, New York, 10467, United States

RECRUITING

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

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

RECRUITING

Regional Center for Infectious Diseases ( Site 0018)

Greensboro, North Carolina, 27401, United States

RECRUITING

Philadelphia Fight Community Health Centers ( Site 0011)

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

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

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

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

Columbia, South Carolina, 29203, United States

RECRUITING

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

Memphis, Tennessee, 38105, United States

RECRUITING

Meharry Medical College ( Site 0013)

Nashville, Tennessee, 37208, United States

RECRUITING

Central Texas Clinical Research ( Site 0014)

Austin, Texas, 78705, United States

RECRUITING

Saint Hope Foundation, Inc. ( Site 0015)

Bellaire, Texas, 77401, United States

RECRUITING

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

Seattle, Washington, 98104, United States

RECRUITING

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

CABA, Buenos Aires, C1002ABN, Argentina

RECRUITING

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

CABA, Buenos Aires, C1425AGC, Argentina

RECRUITING

Fundación Huésped ( Site 0350)

CABA, Buenos Aires, C1427CEA, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Fundación IDEAA ( Site 0351)

Buenos Aires, C1405CKC, Argentina

RECRUITING

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

Manaus, Amazonas, 69040-000, Brazil

RECRUITING

Obras Sociais Irma Dulce ( Site 0406)

Salvador, Estado de Bahia, 41680-430, Brazil

RECRUITING

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

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Hospital Geral de Nova Iguacu ( Site 0411)

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

RECRUITING

Ricardo Diaz Scientific Solutions ( Site 0402)

São Paulo, São Paulo, 04030-030, Brazil

RECRUITING

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

São Paulo, São Paulo, 04121-000, Brazil

RECRUITING

Hospital das Clinicas FMUSP ( Site 0401)

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)

Rio de Janeiro, 21040-360, Brazil

RECRUITING

Universidad San Sebastian - Providencia ( Site 0454)

Santiago, Region M. de Santiago, 7500000, Chile

RECRUITING

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

Santiago, Region M. de Santiago, 8380420, Chile

RECRUITING

Hospital Dr. Hernán Henríquez Aravena ( Site 0451)

Temuco, Región de la Araucanía, 4781151, Chile

RECRUITING

IPS SURA San Diego ( Site 0500)

Medellín, Antioquia, 50016, Colombia

RECRUITING

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

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Hospital Universitario San Ignacio ( Site 0503)

Bogotá, Bogota D.C., 110231, Colombia

RECRUITING

Fundación Valle del Lili ( Site 0502)

Cali, Valle del Cauca Department, 760036, Colombia

RECRUITING

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

Santo Domingo, Nacional, 10104, Dominican Republic

RECRUITING

Endocardio ( Site 1003)

Santo Domingo, Nacional, 10147, Dominican Republic

RECRUITING

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

Santo Domingo de Guzman, Santo Domingo Province, 10306, Dominican Republic

RECRUITING

Hopital Saint Louis ( Site 0100)

Paris, 75010, France

RECRUITING

Hôpital Tenon ( Site 0102)

Paris, 75970, France

RECRUITING

Hopital Bichat - Claude Bernard ( Site 0101)

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

RECRUITING

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

Guatemala City, 01009, Guatemala

RECRUITING

MEDI-K ( Site 1053)

Guatemala City, 01009, Guatemala

RECRUITING

CELAN,S.A ( Site 1052)

Guatemala City, 01010, Guatemala

RECRUITING

Universiti Malaya Medical Centre ( Site 0651)

Kuala Lumpur, 50603, Malaysia

RECRUITING

Asociación Civil Selva Amazónica ( Site 0556)

Iquitos, Loreto, 16001, Peru

RECRUITING

Via Libre ( Site 0551)

Lima, 15001, Peru

RECRUITING

Policlínico Socios en Salud ( Site 0557)

Lima, 15024, Peru

RECRUITING

Investigaciones Medicas en Salud ( Site 0552)

Lima, 15046, Peru

RECRUITING

Asociación Civil Impacta Salud y Educación ( Site 0553)

Lima, 15063, Peru

RECRUITING

Universidad Nacional Mayor De San Marcos ( Site 0555)

Lima, 15081, Peru

RECRUITING

LoveYourself Inc. ( Site 0705)

Mandaluyong, National Capital Region, 1552, Philippines

RECRUITING

Philippine General Hospital ( Site 0700)

Manila, National Capital Region, 1000, Philippines

RECRUITING

Asian Hospital and Medical Center ( Site 0704)

Muntinlupa, National Capital Region, 1780, Philippines

RECRUITING

Foundation For Professional Development ( Site 0257)

King Williams Town, Eastern Cape, 5660, South Africa

RECRUITING

Wits RHI Research Center ( Site 0251)

Johannesburg, Gauteng, 2001, South Africa

RECRUITING

Setshaba Research Centre ( Site 0252)

Pretoria, Gauteng, 0152, South Africa

RECRUITING

Perinatal HIV Research Unit (PHRU) ( Site 0253)

Soweto, Gauteng, 1864, South Africa

RECRUITING

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

Durban, KwaZulu-Natal, 4001, South Africa

RECRUITING

Desmond Tutu Health Foundation ( Site 0250)

Cape Town, Western Cape, 7925, South Africa

RECRUITING

University Hospital Basel ( Site 1102)

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Inselspital Bern ( Site 1103)

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Checkpoint Zurich ( Site 1100)

Zurich, 8005, Switzerland

RECRUITING

Chulalongkorn Hospital ( Site 0807)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Institute of HIV Research and Innovation ( Site 0810)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 0806)

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Research Institute for Health Sciences ( Site 0809)

Muang, Chiang Mai, 50200, Thailand

RECRUITING

Hanoi Medical University Hospital ( Site 0851)

Hanoi, Hanoi, 100000, Vietnam

RECRUITING

Thu Duc General Hospital ( Site 0881)

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: June 29, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): July 22, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AR (5); PE (6); DO (3); ZA (6); FR (3); TH (5); PH (3); CH (3); CO (4); VN (2); US (23); GU (3); CL (3); BR (8); MY (1)