Boston (Feb. 14, 2003) Preliminary 24-week data were presented today from the CONTEXT trial, an open-label, multi-center study evaluating the safety and efficacy of once-a-day (QD) or twice-a-day (BID) dosing of the investigational protease inhibitor (PI) GW433908 (908) boosted with ritonavir (908/r) compared to a third treatment arm with the PI lopinavir/ritonavir (LPV/r, Kaletra) BID in treatment-experienced patients with prior virologic failure. The medications in all three treatment arms were administered as part of combination therapy that included two reverse transcriptase inhibitors (RTIs). In this study, 908 was administered without food or fluid restrictions.
908 is the calcium phosphate ester pro-drug of amprenavir (APV) and was co-discovered by GlaxoSmithKline (GSK) and Vertex Pharmaceuticals (Nasdaq: VRTX).
The primary objective of CONTEXT is to assess antiretroviral response by measuring the time averaged change in viral load (vRNA) from baseline (AAUCMB) at 24 and 48 weeks. Similar efficacy responses were seen in both the 908/r regimens and the LPV/r regimen, meeting the primary endpoint of non-inferiority in this study at 24 weeks.
"In the preliminary analysis of 24-week data, the mean AAUCMB was comparable for all three treatment arms," said Edwin DeJesus, M.D., Infectious Disease Consultants, Altamonte Springs, Fla., lead investigator on the study.
"Although these results are from only 24 weeks of study, these Phase III data on the safety and efficacy of the investigational agent 908 as therapy for HIV in PI-experienced patients with prior virologic failure are encouraging," said Doug Manion, M.D., vice president of Clinical Development, GSK.
CONTEXT is the third of three pivotal trials to support regulatory submission of 908. The 24-week CONTEXT results add to the 48-week results of the NEAT trial, also presented today in Boston, and 48-week data from the SOLO trial, presented in November 2002 at the 6th Page: 1 2 3 4 Related biology news :1
Contact: Amy Kling
Public Communications Inc.
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