A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Condition: HIV-1 Infection
Intervention: Doravirine; Placebo
Intervention description: Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).; Placebo tablets once daily for 7 days.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral
      activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve,
      HIV-1-infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HIV-1-infection ≥3 months prior to screening

          -  Participants with female partner(s) of child-bearing potential must agree to use a
             medically acceptable method of contraception during the study and for 90 days after
             the last dose of study drug

          -  Body Mass Index (BMI) ≤35 kg/m^2

          -  Other than HIV infection, participant's baseline health is judged to be stable

          -  No clinically significant abnormality on electrocardiogram (ECG)

          -  Participant is ART-naïve (defined as having never received any antiretroviral agent or
             ≤30 consecutive days of an investigational antiretroviral agent (excluding an
             Non-Nucleoside Reverse Transcriptase Inhibitor [NNRTI]) or ≤60 consecutive days of
             combination ART not including an NNRTI)

          -  Participant is willing to receive no other ART for the duration of the treatment phase
             of this study.

        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

          -  Participant has used any immune therapy agents or immunosuppressive therapy within 1
             month prior to treatment in this study

          -  Participant has one or more pre-existing risk factors for Torsades de Pointes (New
             York Heart Association Functional Classification II through IV heart failure, familial
             long-QT-syndrome, uncorrected hypokalemia, QTcF >470 msec)

          -  Participant requires or is anticipated to require chronic daily prescription
             medications

          -  Current (active) diagnosis of acute hepatitis due to any cause

          -  History of chronic Hepatitis C virus (HCV) unless there has been documented cure
             and/or patient with a positive serologic test for HCV has a negative HCV viral load.

          -  Positive Hepatitis B surface antigen

          -  Participant is unable to refrain from or anticipates the use of 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, until
             the post-study visit

          -  Participant consumes 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

          -  Participant consumes 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

          -  Participant is an excessive smoker (i.e., more than 10 cigarettes/day) and is
             unwilling to restrict smoking to ≤10 cigarettes per day

          -  Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks
             prior to the prestudy (screening) visit

          -  Participation in another investigational study within 4 weeks prior to the prestudy
             (screening) visit

          -  History of significant multiple and/or severe allergies (including latex allergy), or
             has had an anaphylactic reaction or significant intolerability to prescription or
             non-prescription drugs or food

          -  Current regular user (including use of any illicit drugs) or has a history of drug
             (including alcohol) abuse within approximately 1 year