Incidence of infections in treatment-experienced (TE) patients in the MOTIVATE studies of maraviroc (MVC) plus optimized background therapy (OBT)

Abstract

Background Certain infections occur more frequently in HIV-infected patients some of which are classified as AIDS-defining events. Theoretical concerns have been raised that CCR5 antagonists may have an adverse effect on the immune system. A 4-week immunotoxicology study in cynomolgous monkeys did not demonstrate any adverse effects of MVC on the immune system. MOTIVATE 1 and MOTIVATE 2 are randomized, double-blind, placebo (PBO)-controlled, Phase III studies assessing the safety and efficacy of MVC in TE patients with CCR5-tropic HIV1. In both studies, MVC+OBT demonstrated significantly greater virologic and immunologic efficacy and a similar safety profile compared with PBO+OBT at 48 weeks.