Title:

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

Purpose:

To Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

Objective:

To evaluate the efficacy of MK-8527 qm compared to FTC/TDF ad for the
prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections

Design:

Randomized, active-controlled, parallel-group, multisite, double-blind, double dummy

Population:

Cisgender men, TGW, TGM, and GNB

Coverage:

Vihiga, Nyamira, Nandi, Kisii, Migori

Site:

Kisumu

Duration:

33 Months

Funding:

Merck Sharp & Dohme