drugset / Trial / NCT01353898

Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003)

NCT01353898 ↗

Phase 1 Terminated 12 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice per day) or placebo. Part II will begin after the results of Part I are known; participants will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1 infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.

Timeline

Start
2011-06-21
Primary completion
2012-01-03
Completion
2012-01-03

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1972 Unknown 25 mg Oral
Subject MK-1972 Unknown 50 mg Oral
Subject MK-1972 Unknown 100 mg Oral
Subject MK-1972 Unknown 200 mg Oral
Subject MK-1972 Unknown 800 mg Oral