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ViiV Healthcare Starts Phase III Clinical Programme of Celsentri/Selzentry® (maraviroc) versus Truvada® (tenofovir + FTC), in combination with a Protease Inhibitor in people living with HIV
Date:10/11/2011

LONDON, Oct. 11, 2011 /PRNewswire/ -- ViiV Healthcare announces the start of the Phase III MODERN Study [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen], also known as A4001095, comparing its CCR5-inhibitor, Celsentri/Selzentry® (maraviroc), to emtricitabine/tenofovir (Truvada®), both in combination with darunavir/ritonavir. The 96-week trial will evaluate a two-drug versus three-drug once-daily regimen for the treatment of antiretroviral-naive patients infected with CCR5-tropic HIV-1.

"The treatment of HIV has come a long way, but it is essential that we continue to pursue effective novel treatment strategies that minimise toxicity while maximising tolerability and convenience. The MODERN study will investigate a treatment approach using Celsentri that is designed to meet those goals," said Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "ViiV Healthcare is committed to understanding patient needs and addressing them through innovative treatment approaches that directly reflect what we learn."

Exploration of HIV treatment regimens that don't include a nucleoside reverse transcriptase inhibitor (NRTI), currently recommended as part of standard of care for first line HIV therapy, continues to be an area of interest because of the potential to alleviate some long-term toxicities associated with NRTI-based regimens and preserve future treatment options.  

About MODERNMODERN is a Phase III, 96-week, multi-center, randomised, double-blind, comparative study. It will include approximately 804 antiretroviral-naive patients infected with CCR5-tropic HIV-1 from over 250 sites in the E.U., U.S. and Australia. The primary endpoint for MODERN is the proportion of patients with HIV-1 RNA <50 copies/mL at week 48. Secondary objectives include the proportion of patients with HIV-1 RNA below the limits of assay detection at week 96; change in CD4+ and CD8+ cell counts through 48 an
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