a study of mk-8527 in human immunodeficiency type 1 virus (hiv-1) infected participants (mk-8527-002)

Conditions: Human Immunodeficiency Virus; AIDS Virus

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.

up to five panels (panels a-e) of 6 participants each will be enrolled in a sequential manner. in each panel, participants will receive a single dose of mk-8527 up to 50 mg. historical data from previous single does studies will be used for placebo (control) comparisons.

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