Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003)
Condition: HIV-1 Infection
Intervention: MK-1972; Placebo to MK-1972
Intervention description: MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days; Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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.