Conditions: HIV Infections
Keywords: Treatment Experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 352
Healthy volunteers: no

Brief summary:
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.

Detailed description:
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Arms:
arm 1: raltegravir potassium arm 2: Placebo

Interventions: intervention 1: raltegravir potassium intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks. intervention 2: Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.

Protocol document: