Shionogi-ViiV Healthcare announced on February 3 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 nucleoside reverse transcriptase inhibitor (NRTI) combination Epzicom (Ziagen/Epivir or ABC/3TC).
"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 and CEO of Shionogi, Inc. "We're optimistic that 572 will continue to show promise through this research and in the other ongoing Phase 3 studies that are evaluating it in other HIV treatment regimens."
The SINGLE study 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 Sustiva/Viread/Emtriva (EFV/TDF/FTC). This study will include approximately 800 treatment-naïve patients infected with HIV-1. 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 assessment of the tolerability, long-term safety, and antiviral and immunologic activity of 572-Trii once-daily compared to EFV/TDF/FTC over 96 weeks. Investigators will also evaluate viral resistance in patients experiencing virologic failure.
Together with the planned FDC bioequivalence study (ING114580) comparing the 572-Trii FDC tablet with 572 plus ABC/3TC, the SINGLE study is designed to support a New Drug Application filing for 572-Trii as a new fixed dose combination of 572/ABC/3TC.
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