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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified May 2026 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT07044297
Other Study ID Numbers:
8527-011
First Submitted
June 25, 2025
First Posted
June 28, 2025
Last Update Posted
June 7, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis
Drug: MK-8527Drug: FTC/TDF

Study Design

Study TypeInterventional
Actual Enrollment4390 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis
Study Start DateJuly 30, 2025
Actual Primary Completion Date1yr 1mo from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
MK-8527
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
Oral tablet
FTC/TDF
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
Oral tablet

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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.
  3. 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.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) | Birmingham Alabama, United States, 35222USA Health University Hospitals ( Site 0020) | Mobile Alabama, United States, 36617UCLA Center for Clinical AIDS Research and Education ( Site 0004) | Los Angeles California, United States, 90035Bridge HIV - San Francisco Department of Public Health ( Site 0001) | San Francisco California, United States, 94102Whitman-Walker Institute ( Site 0016) | Washington D.C. District of Columbia, United States, 20032University of Miami RAPID Research ( Site 0003) | Miami Florida, United States, 33136Orlando Immunology Center ( Site 0021) | Orlando Florida, United States, 32803Hope Clinic of the Emory Vaccine Center ( Site 0009) | Decatur Georgia, United States, 30030University of Illinois Chicago ( Site 0027) | Chicago Illinois, United States, 60612University Medical Center New Orleans ( Site 0024) | New Orleans Louisiana, United States, 70112Open Arms Healthcare Center ( Site 0025) | Jackson Mississippi, United States, 39202Rutgers New Jersey Medical School ( Site 0010) | Newark New Jersey, United States, 07103Montefiore Medical Center ( Site 0017) | The Bronx New York, United States, 10467NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008) | Chapel Hill North Carolina, United States, 27514-7064Regional Center for Infectious Diseases ( Site 0018) | Greensboro North Carolina, United States, 27401Philadelphia Fight Community Health Centers ( Site 0011) | Philadelphia Pennsylvania, United States, 19107University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022) | Pittsburgh Pennsylvania, United States, 15213Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007) | Columbia South Carolina, United States, 29203St. Jude Children's Research Hospital ( Site 0026) | Memphis Tennessee, United States, 38105Meharry Medical College ( Site 0013) | Nashville Tennessee, United States, 37208Central Texas Clinical Research ( Site 0014) | Austin Texas, United States, 78705Saint Hope Foundation, Inc. ( Site 0015) | Bellaire Texas, United States, 77401Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002) | Seattle Washington, United States, 98104Centro de Estudios Infectológicos S.A. ( Site 0357) | CABA Buenos Aires, Argentina, C1002ABNCentro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352) | CABA Buenos Aires, Argentina, C1425AGCFundación Huésped ( Site 0350) | CABA Buenos Aires, Argentina, C1427CEAInstituto de Investigaciones Clínicas Mar del Plata ( Site 0353) | Mar del Plata Buenos Aires, Argentina, B7600FZOFundación IDEAA ( Site 0351) | Buenos Aires , Argentina, C1405CKCFundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412) | Manaus Amazonas, Brazil, 69040-000Obras Sociais Irma Dulce ( Site 0406) | Salvador Estado de Bahia, Brazil, 41680-430School of Medicine Federal University of Minas Gerais ( Site 0417) | Belo Horizonte Minas Gerais, Brazil, 30130-100Hospital Geral de Nova Iguacu ( Site 0411) | Nova Iguaçu Rio de Janeiro, Brazil, 26030-380Ricardo Diaz Scientific Solutions ( Site 0402) | São Paulo São Paulo, Brazil, 04030-030Centro de Referência e Treinamento DST/AIDS ( Site 0400) | São Paulo São Paulo, Brazil, 04121-000Hospital das Clinicas FMUSP ( Site 0401) | São Paulo São Paulo, Brazil, 05403-000Instituto Nacional de Infectologia Evandro Chagas ( Site 0407) | Rio de Janeiro , Brazil, 21040-360Hospital Dr. Hernán Henríquez Aravena ( Site 0451) | Temuco Araucania, Chile, 4781151Universidad San Sebastian - Providencia ( Site 0454) | Santiago Region M. de Santiago, Chile, 7500000Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450) | Santiago Region M. de Santiago, Chile, 8380420IPS SURA San Diego ( Site 0500) | Medellín Antioquia, Colombia, 50016Clinica de la Costa S.A.S. ( Site 0501) | Barranquilla Atlántico, Colombia, 080020Hospital Universitario San Ignacio ( Site 0503) | Bogotá Bogota D.C., Colombia, 110231Fundación Valle del Lili ( Site 0502) | Cali Valle del Cauca Department, Colombia, 760032CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001) | Santo Domingo Nacional, Dominican Republic, 10104Endocardio ( Site 1003) | Santo Domingo Nacional, Dominican Republic, 10147Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002) | Santo Domingo de Guzman Santo Domingo Province, Dominican Republic, 10306Hopital Saint Louis ( Site 0100) | Paris , France, 75010Hôpital Tenon ( Site 0102) | Paris , France, 75970Hopital Bichat - Claude Bernard ( Site 0101) | Paris Île-de-France Region, France, 75018Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051) | Guatemala City , Guatemala, 01009MEDI-K ( Site 1053) | Guatemala City , Guatemala, 01009CELAN,S.A ( Site 1052) | Guatemala City , Guatemala, 01010Partners for Health and Development in Africa ( Site 0201) | Nairobi Nairobi City, Kenya, 00506Kargeno Research & Policy Hub ( Site 0200) | Kisumu , Kenya, 40123Impact Research and Development Organisation (IRDO) ( Site 0202) | Kisumu , Kenya, 40141Universiti Malaya Medical Centre ( Site 0651) | Kuala Lumpur , Malaysia, 50603Asociación Civil Selva Amazónica ( Site 0556) | Iquitos Loreto, Peru, 16001Via Libre ( Site 0551) | Lima , Peru, 15001Policlínico Socios en Salud ( Site 0557) | Lima , Peru, 15024Investigaciones Medicas en Salud ( Site 0552) | Lima , Peru, 15046Asociación Civil Impacta Salud y Educación ( Site 0553) | Lima , Peru, 15063Universidad Nacional Mayor De San Marcos ( Site 0555) | Lima , Peru, 15081LoveYourself Inc. ( Site 0705) | Mandaluyong National Capital Region, Philippines, 1552Philippine General Hospital ( Site 0700) | Manila National Capital Region, Philippines, 1000Asian Hospital and Medical Center ( Site 0704) | Muntinlupa National Capital Region, Philippines, 1780Foundation For Professional Development ( Site 0257) | King Williams Town Eastern Cape, South Africa, 5660Wits RHI Research Center ( Site 0251) | Johannesburg Gauteng, South Africa, 2001Setshaba Research Centre ( Site 0252) | Pretoria Gauteng, South Africa, 0152Perinatal HIV Research Unit (PHRU) ( Site 0253) | Soweto Gauteng, South Africa, 1864Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256) | Durban KwaZulu-Natal, South Africa, 4001Desmond Tutu Health Foundation ( Site 0250) | Cape Town Western Cape, South Africa, 7925University Hospital Basel ( Site 1102) | Basel Canton of Basel-City, Switzerland, 4031Inselspital Bern ( Site 1103) | Bern Canton of Bern, Switzerland, 3010Checkpoint Zurich ( Site 1100) | Zurich , Switzerland, 8005Chulalongkorn Hospital ( Site 0807) | Bangkok Bangkok, Thailand, 10330HIV Netherlands Australia Thailand Research Collaboration ( Site 0808) | Bangkok Bangkok, Thailand, 10330Institute of HIV Research and Innovation ( Site 0810) | Bangkok Bangkok, Thailand, 10330Faculty of Medicine Siriraj Hospital ( Site 0806) | Bangkok Bangkok, Thailand, 10700Research Institute for Health Sciences ( Site 0809) | Muang Chiang Mai, Thailand, 50200Hanoi Medical University Hospital ( Site 0851) | Hanoi Hanoi, Vietnam, 100000Thu Duc General Hospital ( Site 0881) | Ho Chi Minh City , Vietnam, 700000
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC