study of mk-1972 in human immunodeficiency virus (hiv)-1 infected participants who have not previously received antiretroviral therapy (mk-1972-003)

Conditions: HIV-1 Infection

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.


Eligibility criteria:
inclusion criteria * stable baseline health. * appropriate use of contraception; condom protection with pregnant partners. * documented hiv-1 positive * anti-retroviral therapy (art)-naïve, defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent, excluding an integrase inhibitor, or ≤60 consecutive days of combination art excluding an integrase inhibitor. * no investigational agent or licensed art within 30 days of study drug administration. * diagnosis of hiv-1-infection ≥ 3 months prior to screening. exclusion criteria * history of stroke, chronic seizures, or major neurological disorder. * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of hiv-1 infection), renal, respiratory, or genitourinary abnormalities or diseases. * history of clinically significant neoplastic disease. * use of any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study. * requirement for chronic daily prescription medications. * current (active) diagnosis of acute hepatitis due to any cause. * history of chronic hepatitis c unless there has been documented cure and/or participant with a positive serologic test for hepatitis c virus (hcv) has a negative hcv viral load. * positive hepatitis b surface antigen. * refusal to stop using any medication, including prescription and non-prescription drugs or herbal remedies (such as st. john's wort \[hypericum perforatum\]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals), until the post-study visit. * consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day. * consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day. * smoker of more than 10 cigarettes/day unwilling to restrict smoking to ≤10 cigarettes per day. * major surgery, donation or loss of 1 unit of blood (approximately 500 ml) or participation in another investigational study within 4 weeks prior to screening. * history of significant multiple and/or severe allergies (including latex allergy), or an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. * current regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year. participants with a positive cannabis test with no evidence of drug-dependency may be enrolled at the discretion of the investigator. * history of hepatic or gallbladder disease or history of clinically significant abnormalities in liver function tests, or history of gilbert's syndrome, or history of elevated unconjugated bilirubin.