Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
Condition: HIV-1 Infection
Intervention: MK-8504
Intervention description: After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and
      anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in
      ART-naïve Human Immunodeficiency Virus (HIV)-1 infected participants. The primary hypothesis
      is that MK-8504, at a dose that is sufficiently safe and well tolerated, has superior
      antiretroviral activity compared to placebo, as measured by change from baseline in plasma
      HIV-1 ribonucleic acid (RNA) at 168 hours post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant and non-breast feeding female

          -  Have a Body Mass Index (BMI) ≤35 kg/m^2

          -  Other than HIV infection, have stable baseline health based on medical history,
             physical examination, vital sign measurements, and laboratory safety test

          -  Is documented HIV-1 positive

          -  Is diagnosed with HIV-1 infection 3 months prior to screening

          -  Is ART-naïve

          -  Has not received an investigational agent or marketed ART within 30 days of study drug
             administration and is willing to receive no other ART for the duration of this study

          -  Agree to follow smoking and other trial restrictions

        Exclusion Criteria:

          -  Is mentally or legally institutionalized / incapacitated, has significant emotional
             problems at the time of pretrial (screening) visit or expected during the conduct of
             the trial 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 or major neurological (including stroke and chronic
             seizures) abnormalities or diseases

          -  Has a history of cancer (malignancy)

          -  Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex
             allergy), or has had an anaphylactic reaction or significant intolerability (i.e.
             systemic allergic reaction) to prescription or non-prescription drugs or food

          -  Is positive for hepatitis B surface antigen

          -  Has a history of chronic Hepatitis C

          -  Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4
             weeks prior to the pretrial (screening) visit.

          -  Has participated in another investigational trial within 4 weeks or 5 half-lives,
             whichever is greater, prior to the Day 1 Dosing visit

          -  Is unable to refrain from or anticipates the use of any medication, including
             prescription and non-prescription drugs or herbal remedies beginning approximately 2
             weeks (or 5 half-lives) prior to administration of the initial dose of trial drug,
             throughout the trial, until the post-trial visit

          -  Consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day

          -  Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola,
             energy-drinks, or other caffeinated beverages per day

          -  Is an excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to
             restrict smoking to ≤10 cigarettes per day

          -  Have clinically significant abnormality on the electrocardiogram (ECG) performed at
             the prestudy (screening) visit and/or prior to administration of the initial dose of
             study drug

          -  Has a positive urine drug screen (except for cannabis) at screening and/or predose,
             rechecks are allowed