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news.ViiV Healthcare has begun the Phase III clinical trial of once-daily dosing for Celsentri/Selzentry in combination with a protease inhibitor to treat naive HIV patients.
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The study MODERN [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen] or A4001095 will test the efficacy of Celsentri/Selzentry (maraviroc) versus emtricitabine/tenofovir (Truvada), both in combination with darunavir/ritonavir.
MODERN will span over 96-weeks to test two-drug versus three-drug once-daily regimen for the treatment of antiretroviral-naive patients infected with CCR5-tropic HIV-1.
The trial will enroll nearly 804 subjects.
The primary endpoint is the proportion of patients with HIV-1 RNA at week 48, while the secondary objectives comprise the proportion of patients with HIV-1 RNA below the limits of assay detection at week 96.