Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Shionogi-ViiV Healthcare has enrolled the first patient in a clinical study designed to support a new fixed dose combination (FDC) therapy for the treatment of HIV.
Subscribe to our email newsletter
The new investigational regimen, termed 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).
The multi-centre, multinational, double-blind, two arm study is designed to evaluate the efficacy and safety of 572-Trii (572 plus ABC/3TC) with favirenz/tenofovir/emtricitabine (EFV/TDF/FTC).
The primary endpoint of the 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 evaluating the tolerability, long-term safety, and antiviral and immunologic activity of 572-Trii once-daily compared to EFV/TDF/FTC over 96 weeks.
The study will also evaluate viral resistance in patients experiencing virologic failure.