Actively Recruiting
Phase 3 Study Comparing Monthly MK-8527 to Daily FTCTDF for Preventing HIV-1 Infection
Led by Merck Sharp & Dohme LLC · Updated on 2026-08-10
4390
Participants Needed
81
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.
CONDITIONS
Brief Title
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Research Team
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