Merck Launches Phase III Trial of Once-Monthly Oral HIV PrEP Candidate MK-8527

Local time on June 29, MSDA project has been registered on the ClinicalTrials.gov official websiteEvaluation of the Efficacy and Safety of Once-Monthly Oral MK-8527 for HIV-1 Pre-Exposure ProphylaxisPhase III Clinical Trial（MK-8527-011）。

Source: ClinicalTrials.gov Official Website

This is a randomized,Double-blind, Active DrugPhase III clinical study with placebo control, planned enrollment4,390 subjects, The inclusion criteria are shown in the figure below.

Source: ClinicalTrials.gov Official Website

The medication regimen for the experimental group was: once per month.MK-8527（11 mg）+ Once daily withFTC/TDF MatchedPlacebo treatment, up to 2 years. Afterward, participants will receive open-labelFTC/TDF（200 mg/245 mg）Once-daily treatment for 28 days.

Control Group ReceivedOnce DailyFTC/TDF（200 mg/245 mg）+ Once a month withMK-8527 matched placebo treatment for up to 2 years.Thereafter, subjects will receive open-labelFTC/TDF（200 mg/245 mg）Once-daily treatment for 28 days.

The primary endpoint is the number of subjects diagnosed with HIV-1 infection, having experienced at least one adverse event.（AE）The number of subjects and the number of subjects who discontinued the study intervention due to adverse events.

The study is expected to begin on July 31, 2025, and end on October 20, 2027.

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