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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis

In brief

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

Key facts

Study ID

NCT07044297

Run by

Merck Sharp & Dohme LLC

People needed

4390

Starts

2025-07-31

Expected to finish

2027-07-22

Last updated by the study team

2026-08-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USA Health University Hospitals ( Site 0020) — Mobile, Alabama, United States (enrolling)
• University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) — Birmingham, Alabama, United States (enrolling)
• Bridge HIV - San Francisco Department of Public Health ( Site 0001) — San Francisco, California, United States (enrolling)
• Whitman-Walker Institute ( Site 0016) — Washington D.C., District of Columbia, United States (enrolling)
• UCLA Center for Clinical AIDS Research and Education ( Site 0004) — Los Angeles, California, United States (enrolling)
• Orlando Immunology Center ( Site 0021) — Orlando, Florida, United States (enrolling)
• Hope Clinic of the Emory Vaccine Center ( Site 0009) — Decatur, Georgia, United States (enrolling)
• University of Illinois Chicago ( Site 0027) — Chicago, Illinois, United States (enrolling)
• University Medical Center New Orleans ( Site 0024) — New Orleans, Louisiana, United States (enrolling)
• Open Arms Healthcare Center ( Site 0025) — Jackson, Mississippi, United States (enrolling)
• University of Miami RAPID Research ( Site 0003) — Miami, Florida, United States (enrolling)
• Montefiore Medical Center ( Site 0017) — The Bronx, New York, United States (enrolling)
• NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008) — Chapel Hill, North Carolina, United States (enrolling)
• Regional Center for Infectious Diseases ( Site 0018) — Greensboro, North Carolina, United States (enrolling)
• Philadelphia Fight Community Health Centers ( Site 0011) — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022) — Pittsburgh, Pennsylvania, United States (enrolling)
• Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007) — Columbia, South Carolina, United States (enrolling)
• St. Jude Children's Research Hospital ( Site 0026) — Memphis, Tennessee, United States (enrolling)
• Meharry Medical College ( Site 0013) — Nashville, Tennessee, United States (enrolling)
• Central Texas Clinical Research ( Site 0014) — Austin, Texas, United States (enrolling)
• Saint Hope Foundation, Inc. ( Site 0015) — Bellaire, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002) — Seattle, Washington, United States (enrolling)
• Centro de Estudios Infectológicos S.A. ( Site 0357) — CABA, Buenos Aires, Argentina (enrolling)
• Rutgers New Jersey Medical School ( Site 0010) — Newark, New Jersey, United States (enrolling)
• Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412) — Manaus, Amazonas, Brazil (enrolling)

Full record on ClinicalTrials.gov

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