NCT05494736

MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL. A total of 4 arms was initially planned but Arm D was never initiated as the primary objectives were achieved following completion of Arms A to C.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	MK-8527	MK-8527 capsule taken by mouth.

Timeline

• Start date: 2022-11-17
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2022-08-10
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

4 sites across 2 countries: Romania, South Africa

Regulatory

• FDA-regulated drug study