HOME >> BIOLOGY >> NEWS
24-Wk data from CONTEXT trial comparing GW433908/ritonavir QD & BID to Lopinavir/ritonavir BID

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
'"/>

Contact: Amy Kling
akling@pcipr.com
312-558-1770
Public Communications Inc.
14-Feb-2003


Page: 1 2 3 4

Related biology news :

1. Phase II trials of second-generation antisense cancer drug planned following successful early study
2. Innovative ceramic-on-metal hip replacements to undergo clinical trials
3. Creation of the UK Clinical Research Collaboration will boost clinical trials in UK
4. Novel therapeutic bortezomib moves to phase II trial in lung cancer patients
5. Pharmacogenomics could replace trial-and-error with science from the human genome
6. Wilex & Fox Chase Cancer Center begin trial w/ novel compound targeting tumor invasion & metastasis
7. Small trial shows daclizumab add-on therapy improves MS outcome
8. Tigecycline - antibiotic evaluated in surveillance trial
9. OneWorld Health completes enrollment, treatment in Phase III India trial
10. Landmark, pivotal Phase IIb/III trial of biotoxin for cancer pain begins
11. First large-scale trial of genetically personalised treatment for breast cancer to start soon

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/8/2017)... , Feb. 7, 2017 Report Highlights ... by 2021 from $8.3 billion in 2016 at a ... to 2021. Report Includes - An overview of ... market trends, with data from 2015 and 2016, and ... - Segmentation of the market on the basis of ...
(Date:2/3/2017)... ANTONIO , Feb. 3, 2017  Texas Biomedical Research ... Dr. Larry Schlesinger as the Institute,s new ... Texas Biomed effective May 31, 2017. He is currently the ... Director of the Center for Microbial Interface Biology at Ohio ... Schlesinger as the new President and CEO of Texas Biomed," ...
(Date:2/1/2017)... , February 1, 2017 IDTechEx Research, ... on emerging technology, announces the availability of a new report, ... Continue Reading ... ... industrial and collaborative robots. Source: IDTechEx Report "Sensors for Robotics: Technologies, ...
Breaking Biology News(10 mins):
(Date:2/22/2017)... ... February 22, 2017 , ... ... (TOPEC), the leading medical education provider of women’s health, primary care, and ... Accreditation Council for Continuing Medical Education (ACCME). ACCME’s Accreditation with Commendation is ...
(Date:2/22/2017)... ... February 22, 2017 , ... LabRoots , the ... from around the world, is pleased to announce the launch of a new scholarship ... mathematics (STEM) fields. , This merit-based scholarship is open to all high school seniors, ...
(Date:2/22/2017)... SAN DIEGO , Feb. 22, 2017 ... reported the results of a study that validated the ... pathogens that are associated with increased mortality in immune-suppressed ... transplant patients. The objective of the ... capture of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Herpes ...
(Date:2/22/2017)... SAN DIEGO , Feb. 22, ... (OTCQB:CELZ) announced today expansion of its translational research ... product through establishment of laboratory facilities in San ... the San Diego BioLabs facility, a biotechnology incubator ... and Sanofi. In November 2016, the ...
Breaking Biology Technology:
Cached News: