MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)
Condition: HIV-1 Infection
Intervention: MK-8583
Intervention description: A single oral dose of MK-8583 in capsule form
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 5.0
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 the tenofovir prodrug, MK-8583 monotherapy in
      ART-naïve, HIV-1 infected participants. The primary hypothesis is that at a dose that is
      sufficiently safe and generally well tolerated, MK-8583 has superior anti-retroviral activity
      compared to historical placebo, as measured by change from baseline in plasma HIV-1
      ribonucleic acid (RNA) (log10 copies/mL) at 168 hours post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male with female partner(s) of child-bearing potential use required methods of birth
             control.

          -  Female of reproductive potential must demonstrate a nongravid state at the pretrial
             (screening) visit and agree to use acceptable methods of birth control beginning at
             the pretrial (screening) visit, throughout the trial and until 30 days following
             cessation of treatment.

          -  Postmenopausal female, defined as without menses for at least 1 year and have a
             documented follicle stimulating hormone (FSH) level in the postmenopausal range at
             pretrial (screening).

          -  Surgically sterile female's status is post hysterectomy or oophorectomy.

          -  Is documented HIV-1 positive

          -  Is diagnosed with HIV-1 infection ≥ 3 months prior to screening.

          -  Is ART-naïve, defined as having never received any anti-retroviral agent; or ≤ 30
             consecutive days of an investigational anti-retroviral agent, excluding a nucleoside
             reverse transcriptase inhibitor (NRTI), or ≤ 60 consecutive days of combination ART
             not including a NRTI.

        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 over 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 unless there has been documented cure.

          -  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 pre-trial (screening) visit.

          -  Uses or anticipates using 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, wine or distilled spirits per
             day.

          -  Consumes excessive amounts of 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.

          -  Has a positive urine drug screen (except for cannabis) at screening and/or pre-dose.

          -  Has received any investigational agent or any anti-retroviral agent within 60 days of
             study drug administration; or intends to receive any ART during this study.