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Shionogi-ViiV Healthcare LLC Initiates Phase III Clinical Programme for Investigational Once-Daily HIV Integrase Inhibitor
Date:10/21/2010

d twice daily over 48-weeks. Secondary objectives include the assessment of antiviral activity of '572 compared to RAL at 96-weeks, to compare the tolerability, long-term safety and antiviral and immunologic activity of '572 to RAL, and to evaluate viral resistance in subjects experiencing virological failure.

SAILING Study Design (ING111762) SAILING is a Phase III, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will include approximately 688 HIV-1 infected treatment-experienced, integrase-naive subjects.  The non-inferiority study will assess the antiviral efficacy of '572 compared to RAL.

The primary objective for SAILING will be to demonstrate the antiviral efficacy of '572 50mg once-daily compared to RAL 400mg twice-daily both in combination with a background regimen consisting of one to two fully active agents at 48-weeks. Secondary objectives will evaluate the long-term antiviral activity, pharmacokinetics (PK), the relationship between PK and antiviral activity, tolerability and safety of '572 versus RAL.

About Shionogi-ViiV Healthcare LLC'572 is the lead compound in Shionogi-ViiV Healthcare LLC. It is currently the only once-daily, unboosted integrase inhibitor in Phase III clinical development. Shionogi-ViiV Healthcare LLC is also developing other second-generation integrase inhibitors, including S/GSK1265744, currently in Phase II development.

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 approac
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SOURCE Shionogi-ViiV Healthcare LLC
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