drugset / Trial / NCT03188523

Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)

NCT03188523 ↗

Phase 1 Completed 12 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in ART-naïve Human Immunodeficiency Virus (HIV)-1 infected participants. The primary hypothesis is that MK-8504, at a dose that is sufficiently safe and well tolerated, has superior antiretroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours post-dose.

Timeline

Start
2017-09-08
Primary completion
2018-05-21
Completion
2018-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8504 Unknown 100 mg Oral
Subject MK-8504 Unknown 240 mg Oral