Conditions: HIV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 802
Healthy volunteers: no

Brief summary:
To 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.

Detailed description:

Arms:
arm 1: Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks arm 2: Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks

Interventions: intervention 1: Reformulated Raltegravir intervention 2: Raltegravir intervention 3: TRUVADA™ intervention 4: Placebo to Reformulated Raltegravir intervention 5: Placebo to Raltegravir
Intervention descriptions: intervention 1: Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily intervention 2: Raltegravir 400 mg tablet orally twice daily intervention 3: Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label) intervention 4: Placebo to reformulated raltegravir 2 tablets orally once daily intervention 5: Placebo to raltegravir 1 tablet orally twice daily

Protocol document: