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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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