Status:

RECRUITING

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Human Immunodeficiency Virus (HIV)

HIV Pre-Exposure Prophylaxis

Eligibility:

All Genders

16+ years

Phase:

PHASE3

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 HI...

Eligibility Criteria

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

Key Trial Info

Start Date :

July 31 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 22 2027

Estimated Enrollment :

4390 Patients enrolled

Trial Details

Trial ID

NCT07044297

Start Date

July 31 2025

End Date

July 22 2027

Last Update

April 13 2026

Active Locations (78)

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Page 1 of 20 (78 locations)

1

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

Birmingham, Alabama, United States, 35222

2

USA Health University Hospitals ( Site 0020)

Mobile, Alabama, United States, 36617

3

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

Los Angeles, California, United States, 90035

4

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

San Francisco, California, United States, 94102