A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis
Merck Sharp & Dohme LLC
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
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- Yes
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),…
Interventions
- DrugMK-8527
Oral tablet
- DrugFTC/TDF
Oral tablet
- DrugPlacebo to MK-8527
Placebo tablet matched to MK-8527
- DrugPlacebo to FTC/TDF
Placebo tablet matched to FTC/TDF
Locations (78)
- University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)Birmingham, Alabama
- USA Health University Hospitals ( Site 0020)Mobile, Alabama
- UCLA Center for Clinical AIDS Research and Education ( Site 0004)Los Angeles, California
- Bridge HIV - San Francisco Department of Public Health ( Site 0001)San Francisco, California
- Whitman-Walker Institute ( Site 0016)Washington D.C., District of Columbia
- University of Miami RAPID Research ( Site 0003)Miami, Florida