7
Raltegravir:
Clinical Development Program
*Protocols 004/005: Phase 2 dose-finding trials in naïve/treatment-experienced patients, respectively
*Protocols 018/019: Identical double-blind, placebo-controlled Phase 3 trials in HIV-1 treatment-experienced patients
–Week 16 primary endpoint because Phase 2 trials demonstrated robust activity
–Allowed to submit NDA with 100% of Week 16 data and about 60% of Week 24 data
*
Phase 2 and 3 data provide evidence of the safety and efficacy of Raltegravir . Specifically, trials 18 and 19 were designed identically and differed by geographic location only. Studies 4 and 5 were phase 2 dose-finding trials in naïve and treatment experienced patients respectively.