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Shionogi-ViiV Healthcare Starts Phase III Trial for '572-Trii' Fixed-Dose Combination HIV Therapy
Date:2/3/2011

LONDON, Feb. 3, 2011 /PRNewswire/ -- Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.  The new investigational regimen, known as 572-Trii, will combine the investigational integrase inhibitor S/GSK1349572 ('572) and ViiV Healthcare's combination nucleoside reverse transcriptase inhibitor (NRTI) Kivexa®/Epzicom® (ABC/3TC).

"ViiV Healthcare's goal is to understand and be responsive to the needs of people living with HIV," stated Dominique Limet, Chief Executive Officer, ViiV Healthcare. "With this programme, we are seeking to create an integrase-based, once-daily fixed dose combination that helps meet  patient needs.  We know that even with the successes of current therapies, patients still need additional treatment options and we will continue to evaluate existing and pipeline compounds for new combination therapies."  

"The study of a fixed-dose combination therapy that includes '572 is a signal of Shionogi and ViiV Healthcare's confidence in the compound's potential," said Dr. Sapan Shah, President & CEO, Shionogi Inc. "We're optimistic that '572 will continue to show promise through this research and in the other ongoing Phase III studies that are evaluating it in other HIV treatment regimens."

About the Study: SINGLE (ING114467)The SINGLE study (ING114467) is a multi-centre, multinational, double-blind, two arm study designed to compare the efficacy and safety of 572-Trii ('572 plus ABC/3TC) with that of efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC). This study will include approximately 800 HIV-1 infected treatment-naive patients.

The primary objective for the SINGLE study will be to demonstrate the antiviral activity of 572-Trii once-daily therapy compared to EFV/TDF/FTC over 48 weeks. Secondary objectives include the assessme
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SOURCE Shionogi-ViiV Healthcare, LLC
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