NCT07044297

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,390 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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

Conditions

• Human Immunodeficiency Virus (HIV)
• HIV Pre-Exposure Prophylaxis

Interventions

Type	Name	Description
DRUG	MK-8527	Oral tablet
DRUG	FTC/TDF	Oral tablet
DRUG	Placebo to MK-8527	Placebo tablet matched to MK-8527
DRUG	Placebo to FTC/TDF	Placebo tablet matched to FTC/TDF

Timeline

• Start date: 2025-07-31
• Primary completion: 2027-07-22
• Completion: 2027-07-22
• First posted: 2025-06-29
• Last updated: 2026-04-13

Locations

78 sites across 15 countries: United States, Argentina, Brazil, Chile, Colombia, Dominican Republic, France, Guatemala, Malaysia, Peru, Philippines, South Africa, Switzerland, Thailand, Vietnam

Regulatory

• FDA-regulated drug study