A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
NCT ID: NCT07044297
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4390 participants
INTERVENTIONAL
2025-07-31
2027-07-22
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
MK-8527
Oral tablet
FTC/TDF
Oral tablet
Placebo to FTC/TDF
Placebo tablet matched to FTC/TDF
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.
FTC/TDF
Oral tablet
Placebo to MK-8527
Placebo tablet matched to MK-8527
Interventions
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MK-8527
Oral tablet
FTC/TDF
Oral tablet
Placebo to MK-8527
Placebo tablet matched to MK-8527
Placebo to FTC/TDF
Placebo tablet matched to FTC/TDF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham, Alabama, United States
USA Health University Hospitals ( Site 0020)
Mobile, Alabama, United States
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Los Angeles, California, United States
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
San Francisco, California, United States
Whitman-Walker Institute ( Site 0016)
Washington D.C., District of Columbia, United States
University of Miami RAPID Research ( Site 0003)
Miami, Florida, United States
Orlando Immunology Center ( Site 0021)
Orlando, Florida, United States
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Decatur, Georgia, United States
University of Illinois Chicago ( Site 0027)
Chicago, Illinois, United States
University Medical Center New Orleans ( Site 0024)
New Orleans, Louisiana, United States
Open Arms Healthcare Center ( Site 0025)
Jackson, Mississippi, United States
Rutgers New Jersey Medical School ( Site 0010)
Newark, New Jersey, United States
Montefiore Medical Center ( Site 0017)
The Bronx, New York, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
Chapel Hill, North Carolina, United States
Regional Center for Infectious Diseases ( Site 0018)
Greensboro, North Carolina, United States
Philadelphia Fight Community Health Centers ( Site 0011)
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
Pittsburgh, Pennsylvania, United States
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
Columbia, South Carolina, United States
Meharry Medical College ( Site 0013)
Nashville, Tennessee, United States
Central Texas Clinical Research ( Site 0014)
Austin, Texas, United States
Saint Hope Foundation, Inc. ( Site 0015)
Bellaire, Texas, United States
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
Seattle, Washington, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
CABA, Buenos Aires, Argentina
Fundación IDEAA ( Site 0351)
Buenos Aires, , Argentina
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo, Nacional, Dominican Republic
Endocardio ( Site 1003)
Santo Domingo, Nacional, Dominican Republic
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)
Santo Domingo de Guzman, Santo Domingo Province, Dominican Republic
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City, , Guatemala
MEDI-K ( Site 1053)
Guatemala City, , Guatemala
CELAN,S.A ( Site 1052)
Guatemala City, , Guatemala
University Hospital Basel ( Site 1102)
Basel, Basel-Landschaft, Switzerland
Inselspital Bern ( Site 1103)
Bern, Canton of Bern, Switzerland
Checkpoint Zurich ( Site 1100)
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8527-011
Identifier Type: OTHER
Identifier Source: secondary_id
2025-520610-58-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1317-6239
Identifier Type: REGISTRY
Identifier Source: secondary_id
8527-011
Identifier Type: -
Identifier Source: org_study_id