A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients

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.

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™.

Inclusion Criteria:

• Patient is male or female 18 years of age or older
• Patient is HIV positive
• Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART

Extension Study:

• The planned extension study did not take place as the study was terminated after the Week 48 analysis.

Exclusion Criteria:

• Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
• Patient has documented resistance to tenofovir or emtricitabine
• Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
• Patient is pregnant or breastfeeding, or expecting to conceive