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

Last updated: October 14, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Hiv (Pediatric)

Aids And Aids Related Infections

Hiv Infections

Treatment

Placebo to FTC/TDF

MK-8527

Placebo to MK-8527

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:
October 20, 2027

Connect with a study center

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

    Santo Domingo 3492908, Nacional 3496024 10104
    Dominican Republic

    Active - Recruiting

  • 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 6201373 10305
    Dominican Republic

    Active - Recruiting

  • CELAN,S.A ( Site 1052)

    Guatemala City 3598132, 01010
    Guatemala

    Active - Recruiting

  • 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

  • University Hospital Basel ( Site 1102)

    Basel, Basel-Landschaft 2661603 4031
    Switzerland

    Active - Recruiting

  • Inselspital Bern ( Site 1103)

    Bern 2661552, Canton of Bern 2661551 3010
    Switzerland

    Active - Recruiting

  • Checkpoint Zurich ( Site 1100)

    Zurich 2657896, 8005
    Switzerland

    Active - Recruiting

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

    Birmingham 4049979, Alabama 4829764 35222
    United States

    Active - Recruiting

  • USA Health University Hospitals ( Site 0020)

    Mobile 4076598, Alabama 4829764 36617
    United States

    Active - Recruiting

  • Bridge HIV - San Francisco Department of Public Health

    San Francisco, California 94102
    United States

    Site Not Available

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

    Los Angeles 5368361, California 5332921 90035
    United States

    Active - Recruiting

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

    San Francisco 5391959, California 5332921 94102
    United States

    Active - Recruiting

  • Whitman-Walker Institute ( Site 0016)

    Washington D.C. 4140963, District of Columbia 4138106 20009
    United States

    Active - Recruiting

  • Orlando Immunology Center ( Site 0021)

    Orlando 4167147, Florida 4155751 32803
    United States

    Active - Recruiting

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

    Decatur 4191124, Georgia 4197000 30030
    United States

    Active - Recruiting

  • University of Illinois Chicago ( Site 0027)

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • Open Arms Healthcare Center ( Site 0025)

    Jackson 4431410, Mississippi 4436296 39202
    United States

    Active - Recruiting

  • Rutgers New Jersey Medical School ( Site 0010)

    Newark 5101798, New Jersey 5101760 07103
    United States

    Active - Recruiting

  • Montefiore Medical Center ( Site 0017)

    The Bronx 5110266, New York 5128638 10467
    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 4469146, North Carolina 4482348 27401
    United States

    Active - Recruiting

  • Philadelphia Fight Community Health Centers ( Site 0011)

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

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

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

  • Meharry Medical College ( Site 0013)

    Nashville 4644585, Tennessee 4662168 37208
    United States

    Active - Recruiting

  • Saint Hope Foundation, Inc

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Central Texas Clinical Research ( Site 0014)

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

  • Saint Hope Foundation, Inc. ( Site 0015)

    Bellaire 4673353, Texas 4736286 77401
    United States

    Active - Recruiting

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

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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