Trial intelligence / Profile preview

MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

NCT07044297Phase 3

Key facts

Status: Active, not recruiting
Start: Jul 2025
Primary completion: Jul 2027
Countries: 16
Sponsor: Merck & Co.
Modality: Small Molecules

Drugs: mk-8527
Conditions: human immunodeficiency virus infection (HIV)

Overview

Phase 3, randomised, double-blind trial of mk-8527 in human immunodeficiency virus infection (HIV) (2 arms), sponsored by Merck & Co. Primary endpoints: Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection, Number of Participants Who Experience At Least One Adverse Event (AE) and 1 more. Started Jul 2025; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

MK-8527
Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to FTC/TDF once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
FTC/TDF
Participants will receive 200 mg FTC/245 mg TDF QD and placebo to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Who it enrols

HIV-uninfected individuals (cisgender men, transgender women, transgender men, or gender nonbinary) who have had condomless receptive anal sex and are at risk for HIV, weighing >=35 kg. Excludes those with hepatitis B, recent malignancies, or prior use of long-acting HIV prevention products.

Endpoints

Primary

Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) InfectionUp to approximately 2 years
Number of Participants Who Experience At Least One Adverse Event (AE)Up to approximately 2 years
Number of Participants Who Discontinue Study Intervention Due to an AEUp to approximately 2 years

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