single-dose study of mk-4250 monotherapy in anti-retroviral therapy-naive, human immunodeficiency virus (hiv)-1 infected participants (mk-4250-002)

Conditions: HIV-1 Infection

Summary: the study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of mk-4250 monotherapy in anti-retroviral therapy (art)-naïve, hiv-1 infected participants. the primary hypothesis of the study is that at a dose that is sufficiently safe and generally well tolerated, mk-4250 has superior antiretroviral activity compared to a historical placebo, as measured by change from baseline in plasma hiv-1 ribonucleic acid (rna) (log10 copies/ml) at 168 hours postdose.

the study consists of 5 panels; panel c (mk-4250 ≤600 mg) was removed from the study with protocol amendment 1.

Eligibility criteria:
inclusion criteria: * male or non-pregnant and non-breast feeding female * if female with reproductive potential: must demonstrate a serum β-human chorionic gonadotropin (β -hcg) level consistent with the nongravid state and agree to use a highly effective method of birth control until 30 days after the dose of trial drug * if postmenopausal female: without menses for at least 1 year and has a documented follicle stimulating hormone (fsh) level in the postmenopausal range at pretrial (screening), and/or status post hysterectomy or oophorectomy * documented hiv-1 positive as determined by a positive enzyme-linked immunosorbent assay (elisa) or quantitative polymerase chain reaction (qt-pcr) with confirmation (e.g., western blot). * no evidence at screening for mutations (e.g., e92q, n55h, q148k, q148r and y143r) affecting susceptibility to integrase strand transfer inhibitors (instis) * diagnosed with hiv-1 infection ≥ 3 months prior to screening or confirmed chronic hiv infection * screening plasma cluster of differentiation (cd) 4+ t cell count of \>200/mm\^3 * screening plasma hiv-1 rna ≥5,000 copies/ml within 30 days prior to the treatment phase of this study * anti-retroviral therapy (art)-naïve, which is defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent which is not an insti and no exposure to such an investigational antiretroviral agent within 60 days prior to screening or ≤60 consecutive days of combination art which does not include an insti and no exposure to such art within 60 days prior to screening * never received any insti * willing to receive no other art for the duration of the treatment phase of this study * body mass index (bmi) ≤35 kg/m\^2 * other than hiv infection, have baseline health judged to be stable exclusion criteria: * mentally or legally institutionalized / incapacitated, or 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 within the last 5 years * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of hiv-1 infection), renal, respiratory, genitourinary or major neurological abnormalities or diseases * history of cancer (malignancy). exceptions: (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix; (2) other malignancies which have been successfully treated ≥10 years prior to the pretrial (screening) visit with no evidence of recurrence; or, (3) deemed highly unlikely to sustain a recurrence for the duration of the trial * history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy); anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or non-prescription drugs or food; or hereditary galactose intolerance, lactose deficiency, or glucose-galactose malabsorption. * positive for hepatitis b surface antigen * history of chronic hepatitis c (hcv) infection. participants with a documented cure and/or a positive serologic test for hcv with a negative hcv viral load may be included * major surgery or donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the pretrial (screening) visit * participated in another investigational trial within 4 weeks prior to the day 1 dosing visit. the 4 week window will be derived from the date of the last trial medication and / or blood collection in a previous trial and/or an adverse event related to trial drug to the day 1 dosing visit of the current trial * unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks 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 (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. participants who consume 4 glasses of alcoholic beverages per day may be enrolled * consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day * excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day * cardiac qtc interval ≥470 msec (for males) or ≥480 msec (for females) * positive urine drug screen (except for cannabis) at screening and/or predose; rechecks are allowed * is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.