Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

• Status: Active, not recruiting
• Trial end date: 2024-12-05
• Target enrollment: 0
• Participant gender: All

Summary

This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

• Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization

• Has low-risk of HIV infection

• Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse

Exclusion Criteria:

• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator

• Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])

• Prior use of MK-8527 or islatravir (MK-8591)