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

2011-10-20

First large-scale Phase III clinical trial of once-daily dosing for Celsentri/Selzentry in combination with a protease inhibitor in treatment naive HIV patients
 
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 MODERN
MODERN 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 and 96 weeks; assessment of the safety and tolerability of Celsentri including the effects on peripheral fat distribution and trunk to limb fat ratio; the effects on bone mineral density; utility of genotypic and phenotypic testing; and tropism change and evolution of viral resistance.
 
MODERN is also the first large Phase III trial that will compare the performance of a genotypic test with a phenotypic test to prospectively assess the CCR5 status of the patients and to determine eligibility for Celsentri/Selzentry®. Patients will be randomised to undergo screening with either the genotypic or phenotypic test. Genotypic tropism testing in the MODERN study is provided by Siemens Healthcare Diagnostics and phenotypic testing (Trofile®) by Monogram Biosciences.
 
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (NYSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Our aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
 
About Tropism Testing
HIV enters a CD4 cell by attaching to one of two types of co-receptors, CCR5 and CXCR4, and tropism is defined by which co-receptor is used. To determine whether patients may be suitable for Celsentri, they must undergo tropism testing to verify that they have only R5-tropic. Use of Celsentri is not recommended in patients who have X4 or dual/mixed tropic HIV-1 because efficacy was not demonstrated in a Phase II study of this patient group.
 
 
 
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