Shionogi-ViiV Healthcare has enrolled the first patient in a clinical study to support a fixed-dose combination therapy to treat HIV.
The investigational regimen, termed as 572-Trii, will combine investigational integrase inhibitor S/GSK1349572 and ViiV Healthcare’s combination nucleoside reverse transcriptase inhibitor (NRTI) Kivexa/Epzicom (ABC/3TC).
The multi-centre, multinational, double-blind, two arm study is designed to evaluate the efficacy and safety of 572-Trii to favirenz / tenofovir / emtricitabine.
The primary endpoint of the study will be to demonstrate the antiviral activity of 572-Trii once-daily therapy compared to favirenz / tenofovir / emtricitabine over 48 weeks.
Secondary objectives include evaluating the tolerability, long-term safety, and antiviral and immunologic activity of 572-Trii once-daily compared to favirenz / tenofovir / emtricitabine over 96 weeks.
The study will also evaluate viral resistance in patients experiencing virologic failure.