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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |