A phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial to evaluate the safety and efficacy of reformulated Raltegravir 1200 mg once daily versus Raltegravir 400 mg twice daily, each in combination with TRUVADA™, in treatment-naïve HIV-1 infected subjects

This study will evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) < 40 copies/mL at Week 48.