The maraviroc expanded access program - safety and efficacy data from an open-label study

HIV Clinical Trials
Adriano LazzarinJuan G Sierra-Madero

Abstract

The maraviroc (MVC) expanded access program (EAP) was initiated to increase MVC availability to patients with limited treatment options. Darunavir (DRV), raltegravir (RAL), and etravirine (ETV) were either recently approved or under regulatory review at study initiation and available for coadministration with MVC. Thus, the safety of MVC in combination with new antiretroviral therapies (ARVs) could be assessed. This open-label safety study of MVC was conducted at 262 sites worldwide in 1032 R5 HIV-positive treatment-experienced patients with limited/no therapeutic options. Study visits included screening, baseline, end of study or early discontinuation, and follow-up 30 days after last dose. Interim visits for HIV-1 RNA and CD4 cell counts occurred according to local HIV infection management guidelines. Safety data were analyzed overall and by subgroup based on ARV combination [MVC+optimized background therapy (OBT), MVC ± OBT+DRV/r, MVC ± OBT+RAL, MVC ± OBT+RAL+DRV/r, MVC ± OBT+RAL+ETV ± DRV/r]. Most (90.3%) adverse events (AEs) were of mild or moderate severity with few grade 3/4 events, discontinuations, or temporary discontinuations/dose reductions due to AEs or serious AEs. Similar results were observed across subgroups. O...Continue Reading

References

Sep 22, 2005·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Christophe MorenoHubert Louis
Jan 19, 2006·The Journal of Experimental Medicine·William G GlassPhilip M Murphy
Jun 16, 2007·The Journal of Infectious Diseases·Roy M GulickUNKNOWN AIDS Clinical Trials Group 5211 Team
Dec 12, 2007·Antimicrobial Agents and Chemotherapy·W G NicholsN Clumeck
Jul 25, 2008·The New England Journal of Medicine·David A CooperUNKNOWN BENCHMRK Study Teams
Oct 4, 2008·The New England Journal of Medicine·Roy M GulickUNKNOWN MOTIVATE Study Teams
Oct 4, 2008·The New England Journal of Medicine·Gerd FätkenheuerUNKNOWN MOTIVATE 1 and MOTIVATE 2 Study Teams
Jul 20, 2010·JAMA : the Journal of the American Medical Association·Melanie A ThompsonUNKNOWN International AIDS Society-USA

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antivirals

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.

Antivirals (ASM)

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.