activity of mk-8504 in anti-retroviral-naïve, human immunodeficiency virus 1 (hiv-1) infected participants (mk-8504-002)

Conditions: HIV-1 Infection

Summary: this study aims to evaluate the safety, tolerability, pharmacokinetics (pk), and anti-retroviral therapy (art) activity of monotherapy with mk-8504 (a tenofovir pro-drug), in art-naïve human immunodeficiency virus (hiv)-1 infected participants. the primary hypothesis is that mk-8504, at a dose that is sufficiently safe and well tolerated, has superior antiretroviral activity compared to placebo, as measured by change from baseline in plasma hiv-1 ribonucleic acid (rna) at 168 hours post-dose.


Eligibility criteria:
inclusion criteria: * male or non-pregnant and non-breast feeding female * have a body mass index (bmi) ≤35 kg/m\^2 * other than hiv infection, have stable baseline health based on medical history, physical examination, vital sign measurements, and laboratory safety test * is documented hiv-1 positive * is diagnosed with hiv-1 infection 3 months prior to screening * is art-naïve * has not received an investigational agent or marketed art within 30 days of study drug administration and is willing to receive no other art for the duration of this study * agree to follow smoking and other trial restrictions 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 of 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 * has 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 day 1 dosing visit * is unable to refrain from or anticipates the use of 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 or distilled spirits per day * consumes excessive amounts, defined as greater than 6 servings 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 * have clinically significant abnormality on the electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug * has a positive urine drug screen (except for cannabis) at screening and/or predose, rechecks are allowed