A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
Condition: HIV-1
Intervention: 1 mg islatravir; 2 mg islatravir; 10 mg islatravir; 30 mg islatravir; 0.5 mg islatravir; 0.25 mg islatravir
Intervention description: Single oral dose of 1 mg islatravir administered following ≥8 hour fast; Single oral dose of 2 mg islatravir administered following ≥8 hour fast; Single oral dose of 10 mg islatravir administered following ≥8 hour fast; Single oral dose of 30 mg islatravir administered following ≥8 hour fast; Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast; Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast
Intervention MeSH terms: Islatravir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral
      therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human
      immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a
      safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1
      ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5
      log (base10) copies/mL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female

          -  Female with reproductive potential agrees to use (or have male partner use) two
             acceptable methods of birth control

          -  Male agrees to use acceptable method of contraception during study and for 90 days
             after last dose of trial drug

          -  Has stable baseline health, other than HIV infection

          -  Has no significantly abnormal electrocardiogram

          -  Is HIV-1 positive

          -  Have a screening plasma HIV-1 RNA ≥ 10,000 copies/mL within 30 days prior to the
             treatment phase of this study. For inclusion in Panel Islatravir Extended Observation,
             participants must also have a screening plasma HIV-1 RNA ≤ 25,000 copies/mL within 30
             days prior to the treatment phase.

          -  Is ART naive

          -  Has not received any investigational agent or marketed ART within 30 days of trial
             drug administration

          -  Is diagnosed with HIV-1 infection >= 3 months prior to screening

          -  Is willing to receive no other ART during treatment phase of study

          -  Has no evidence of mutations conferring resistance to nucleoside reverse transcriptase
             inhibitors (NRTIs)

        Exclusion Criteria:

          -  Is mentally or legally institutionalized/incapacitated, or has significant emotional
             problems, or has a history of clinically significant psychiatric disorder of the last
             5 years

          -  Has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological (outside of HIV-1 infection), renal,
             respiratory, genitourinary, major neurological abnormalities or diseases

          -  Has a history of cancer (malignancy)

          -  Has a history of significant multiple and/or severe allergies, or had an anaphylactic
             reaction to drugs or food

          -  Is positive for hepatitis B surface antigen

          -  Has a history of chronic Hepatitis C

          -  Had major surgery or lost 500 mL of blood with 4 weeks prior to screening visit

          -  Has participated in another investigational trial within 4 weeks prior to dosing visit

          -  Will use any medications, prescribed drugs, or herbal remedies 4 weeks prior to dosing
             of trial drug, up to the post-trial visit

          -  Consumes excessive amounts of alcohol, caffeinated beverages, or tobacco products

          -  Uses illicit drugs or has a history of drug abuse within the prior 2 years