Conditions: HIV
Keywords: HIV Infections Treatment Naïve
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 775
Healthy volunteers: no

Brief summary:
A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Detailed description:
Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.

From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Comparator: Raltegravir 400 mg b.i.d. intervention 2: Experimental: Raltegravir 800 mg q.d. intervention 3: TRUVADA™
Intervention descriptions: intervention 1: Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.) intervention 2: Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d. intervention 3: One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)

Protocol document: