MK 1439-018 Treatment Naive HIV-1 Study (PRO00002560)

Full Name

Treatment Naïve HIV-1 infected subjects/ A Phase 3 Multicenter, Double-blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK 1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA™ or EPZICOM™/KIVEXA™, in Treatment Naïve HIV-1 Infected Subjects (MK 1439-018)

Description

If you agree to participate in this research study, you will be asked to visit the study site about 14 times (screening [Visit 1], Day 1[Visit 2], and at Weeks 2, 4, 8, 16, 24, 36, 48, 60, 72, 84, and 96 [Visits 3 to 13], and 14 days after you complete the study treatment [Visit 14]). You will be assigned by chance to get either MK-1439 100 mg (or matching placebo [looks like MK-1439, but contains no active drug]) or darunavir/ritonavir (800 mg/100 mg) (or matching placebo), both given with either TRUVADA or EPZICOM/KIVEXA. You will have a 1 to 1 chance of getting either MK-1439 100 mg or darunavir/ritonavir). This is a double-blind study, which means that neither nor the study doctor will know to which group you were assigned. To remain blinded, you will receive matching placebo for the alternative treatment. In case of an emergency, the study doctor can find out to which group you were assigned. The following procedures may be done at some or all of your study visits: medical history review; review of prior and current medication; review of any signs or symptoms (side effects) you have experienced; 12-lead electrocardiogram to measure the electrical activity of your heart; physical examination (including height, weight, and vital signs); collection of blood samples for safety assessments (including hepatitis B and C testing), HIV viral load, HIV viral resistance, and immune system assessments, as well as pharmacokinetic (amount of study drug in your blood); collection of urine samples for safety assessments; serum and/or urine pregnancy testing (for women of childbearing potential); dispense study drug and instructions; review your compliance with taking study drug. There is an optional future biomedical research sub-study.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

Must be at least 18 years of age
Must be HIV-1 positive
Must be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents (naïve is defined as having received no ART therapy for the treatment of HIV infection)
Must not have documented or known resistance to study drugs including MK-1439, darunavir, ritonavir, emtricitabine, tenofovir, abacavir and/or lamivudine
Must not have participated in another study with an investigational compound/device within one month prior to signing informed consent
Must not have a current diagnosis of acute hepatitis due to any cause (patients with chronic hepatitis B and C may enter as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function (defined as a serum albumin <2.8 mg/dL or an INR >1.7 in the absence of another explanation for the abnormal laboratory value)