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:
(Date:8/19/2014)... Scientists at the Houston Methodist Research Institute have figured ... using a pipette -- a common laboratory tool that,s ... preliminary test results in a recent issue of the ... "Studying single cells and their unique functions has become ... faculty member Lidong Qin, Ph.D., the project,s principal investigator. ...
(Date:8/19/2014)... of UTSA researchers has been awarded a nearly $40,000 ... Training (NCPTT), an office of the National Park Service ... will fund a one-year study of the energy efficiency ... homes in hot, humid climates. , Radiant barriers are ... that reflect heat back, thereby reducing the amount of ...
(Date:8/19/2014)... used to treat pain, but its effect on ... In a recent study reported on the ... 2014), rat models of an avulsion injury to ... chronic neuropathic pain) were given electroacupuncture stimulation at ... Yanglingquan (GB34). After electroacupuncture therapy, chronic neuropathic pain ...
Breaking Biology News(10 mins):Moving single cells around -- accurately and cheaply 2UTSA researcher awarded $38K+ to evaluate energy efficiency options for historic homes 2UTSA researcher awarded $38K+ to evaluate energy efficiency options for historic homes 3
(Date:8/18/2014)... Sterne, Kessler, Goldstein & Fox P.L.L.C. , an intellectual ... , announced today that it has filed eleven petitions ... U.S. Patent and Trademark Office (USPTO) on behalf of ... BRLI).  These IPR petitions aim to nullify eleven patents ... patents have been asserted against GeneDx in patent infringement ...
(Date:8/18/2014)... 18, 2014 According to ... Research "Life Science Reagents Market(Products- PCR Reagent Kits, ... In-Vitro Diagnostic Reagents and Others; End Users- Commercial ... Laboratories, and Forensic Laboratories)- Global Industry Analysis, Size, ... the global life science reagents market was valued ...
(Date:8/18/2014)... Aug. 18, 2014 Dyadic International, Inc. ... patented and proprietary technologies are used to develop, ... the bioenergy, bio-based chemical, biopharmaceutical and industrial enzyme ... Registration Statement on Form 10 with the U.S. ... Logo - http://photos.prnewswire.com/prnh/20110621/CL06708LOGO ...
(Date:8/16/2014)... Firms in the Scientific ... advisory services to businesses, government bodies and nonprofit ... are highly diverse as operators assist a range ... geological and geophysical consulting services to risk management ... five years, the recovery of the Canadian economy ...
Breaking Biology Technology:Sterne Kessler Files 11 IPR Petitions On Behalf Of GeneDx, Inc., Subsidiary Of BioReference Laboratories, Inc. 2Sterne Kessler Files 11 IPR Petitions On Behalf Of GeneDx, Inc., Subsidiary Of BioReference Laboratories, Inc. 3Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 2Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 3Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 4Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 5Dyadic International Files Form 10 Registration Statement 2Dyadic International Files Form 10 Registration Statement 3Dyadic International Files Form 10 Registration Statement 4Scientific and Economic Consulting in Canada Industry Market Research Report Now Available from IBISWorld 2Scientific and Economic Consulting in Canada Industry Market Research Report Now Available from IBISWorld 3
Cached News: