A Randomized Study of Pharmacokinetics, Efficacy, and Safety of 2 Raltegravir Plus Atazanavir Strategies in ART-Treated Adults

BACKGROUND:New antiretroviral drug classes provide opportunities to explore novel regimens. METHODS:HIV+ adults ( 0.1 all measures). Ninety percent CIs of ATV GMR Cmin [1.30 (90% CI1.08 to 1.58)] and RAL GMR Cmin [0.48 (90% CI0.31 to 0.75)] demonstrated nonequivalence. Seventy-six percent consented to follow-up. There were no serious adverse events and no discontinuations due to adverse events over 48 weeks; HIV RNA remained undetectable. CONCLUSIONS:In virologically suppressed adults, regimens comprising ATV plus RAL were efficacious and safe. ATV q12h troughs were lower than ritonavir-boosted atazanavir q24h; RAL q24h troughs were lower than q12h.