NCT07042945

MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)

Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of MK-4646 Monotherapy in Antiretroviral Therapy-Naïve Participants With HIV-1

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount. The goals of this study are to learn about the safety of MK-4646 and if people tolerate it; and how HIV-1 viral load may decrease after starting to take MK-4646.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	MK-4646	MK-4646 in capsular form administered orally

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-06-22
• Completion: 2026-06-22
• First posted: 2025-06-29
• Last updated: 2026-03-27

Locations

2 sites across 2 countries: Moldova, Romania

Regulatory

• FDA-regulated drug study