Conditions: HIV Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 566
Healthy volunteers: no

Brief summary:
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

Detailed description:

Arms:
arm 1: MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. arm 2: Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.

Interventions: intervention 1: MK-0518 intervention 2: Comparator: efavirenz intervention 3: Comparator: Truvada intervention 4: Comparator: Placebo to MK-0518 intervention 5: Comparator: Placebo to efavirenz
Intervention descriptions: intervention 1: 400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks intervention 2: 600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks intervention 3: One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir) intervention 4: Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks intervention 5: Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks

Protocol document: