A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)
Condition: Human Immunodeficiency Virus; AIDS Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: MK-8527
Intervention description: Single oral capsule
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve
      participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity
      compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid
      (RNA) at 168 hours postdose.
    

Eligibility criteria:

        Inclusion Criteria

          -  Other than HIV infection, is in good health

          -  Is documented HIV-1 positive

          -  Diagnosed with HIV-1 infection ≥ 3 months prior to screening or perform the French
             2008 Haute Autorité de Santé (HAS) Algorithm to confirm chronic HIV.

          -  Is ART-naïve which is defined as having never received any antiretroviral agent or the
             following: ≤30 consecutive days of an investigational antiretroviral agent, excluding
             an Nucleoside reverse transcriptase inhibitors (NRTI), or ≤60 consecutive days of
             combination ART not including an NRTI

          -  Has not received an investigational agent or marketed ART within 30 days of study drug
             administration

          -  Is willing to receive no other ART for the monitoring period of the study

          -  Has a Body Mass Index (BMI) ≤35 kg/m^2, inclusive

          -  If the male participant has a female partner(s) of childbearing potential, he must
             agree to use a medically acceptable method of contraception during the study and for
             120 days after the last dose of study drug. If their partner is pregnant, males must
             agree to use a condom and no additional method of contraception is required for the
             pregnant partner

          -  If the participant is a female with reproductive potential, she must demonstrate a
             serum β-human chorionic gonadotropin (β-hCG) level consistent with the nongravid state
             at the prestudy (screening) visit and agree to use (and/or have their partner use) 2
             acceptable methods of birth control beginning at the prestudy (screening) visit,
             throughout the study (including washout intervals between treatment periods/panels)
             and until 28 days after the last dose of study drug.

          -  If the participant is a postmenopausal female: she is without menses for at least 1
             year and have a documented follicle stimulating hormone (FSH) level in the
             postmenopausal range at prestudy (screening)

          -  If the participant is a surgically sterile female: she is status posthysterectomy, or
             oophorectomy

        Exclusion Criteria

          -  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. Participants with a remote history of
             uncomplicated medical events (eg, uncomplicated kidney stones, as defined as
             spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be
             enrolled in the study at the discretion of the investigator.

          -  Is mentally or legally incapacitated at the time of the prestudy (screening) visit or
             expected during the conduct of the study or has a history of clinically significant
             psychiatric disorder over the last 5 years. Participants who have had situational
             depression may be enrolled in the study at the discretion of the investigator.

          -  History of cancer (malignancy)

          -  History of significant multiple and/or severe allergies or has had an anaphylactic
             reaction or significant intolerability (i.e. systemic allergic reaction) to
             prescription or non-prescription drugs or food.

          -  Positive for hepatitis B surface antigen

          -  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 (VL)

          -  Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4
             weeks

          -  Unable to refrain from or anticipates the use of any medication, including
             prescription and nonprescription drugs or herbal remedies beginning approximately 2
             weeks (or 5 half-lives) prior to administration of the initial dose of study drug,
             throughout the study, until the poststudy visit.

          -  Participated in another investigational study within 4 weeks

          -  Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately
             equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits
             [29.5 mL/1 ounce]) per day.

          -  Consumes excessive amounts, defined as greater than 6 servings (1 serving
             approximately equivalent to 120 mg of caffeine) 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

          -  Has a positive urine drug screen