a study of doravirine (mk-1439) in human immunodeficiency virus type 1 (hiv-1)-infected participants (mk-1439-005)

Conditions: HIV-1 Infection

Summary: this is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (mk-1439) as monotherapy in antiretroviral therapy (art)-naïve, hiv-1-infected participants.


Eligibility criteria:
inclusion criteria: * diagnosis of hiv-1-infection ≥3 months prior to screening * participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug * body mass index (bmi) ≤35 kg/m\^2 * other than hiv infection, participant's baseline health is judged to be stable * no clinically significant abnormality on electrocardiogram (ecg) * participant is art-naïve (defined as having never received any antiretroviral agent or ≤30 consecutive days of an investigational antiretroviral agent (excluding an non-nucleoside reverse transcriptase inhibitor \[nnrti\]) or ≤60 consecutive days of combination art not including an nnrti) * participant is willing to receive no other art for the duration of the treatment phase of this study. exclusion criteria: * history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of hiv-1 infection), renal, respiratory, or genitourinary abnormalities or diseases * history of clinically significant neoplastic disease * participant has used any immune therapy agents or immunosuppressive therapy within 1 month prior to treatment in this study * participant has one or more pre-existing risk factors for torsades de pointes (new york heart association functional classification ii through iv heart failure, familial long-qt-syndrome, uncorrected hypokalemia, qtcf \>470 msec) * participant requires or is anticipated to require chronic daily prescription medications * current (active) diagnosis of acute hepatitis due to any cause * history of chronic hepatitis c virus (hcv) unless there has been documented cure and/or patient with a positive serologic test for hcv has a negative hcv viral load. * positive hepatitis b surface antigen * participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as st. john's wort \[hypericum perforatum\]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study, until the post-study visit * participant consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day * participant consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day * participant is an excessive smoker (i.e., more than 10 cigarettes/day) and is unwilling to restrict smoking to ≤10 cigarettes per day * major surgery, donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy (screening) visit * participation in another investigational study within 4 weeks prior to the prestudy (screening) visit * history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * current regular user (including use of any illicit drugs) or has a history of drug (including alcohol) abuse within approximately 1 year