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:6/3/2016)... 2016 Das DOTM ... Nepal hat ein 44 Millionen ... Kennzeichen, einschließlich Personalisierung, Registrierung und IT-Infrastruktur, an ... und Implementierung von Identitätsmanagementlösungen. Zahlreiche renommierte internationale ... teilgenommen, aber Decatur wurde als konformste und ...
(Date:6/2/2016)... --  The Weather Company , an IBM Business (NYSE: ... in which consumers will be able to interact with IBM ... voice or text and receive relevant information about the product ... have long sought an advertising solution that can create a ... and valuable; and can scale across millions of interactions and ...
(Date:6/1/2016)... YORK , June 1, 2016 ... Technology in Election Administration and Criminal Identification to Boost ... to a recently released TechSci Research report, " Global ... By Region, Competition Forecast and Opportunities, 2011 - 2021", ... 24.8 billion by 2021, on account of growing security ...
Breaking Biology News(10 mins):
(Date:6/22/2016)... , June 22, 2016 Cell ... will allow them to produce up to one ... one lot within one week. These high-quality, consistent ... laboriously preparing cells and spend more time doing ... through a proprietary, high-volume manufacturing process that produces ...
(Date:6/22/2016)...   StockNewsNow.com , The Official MicroCap News Source™, ... Nader Pourhassan , President & CEO of CytoDyn Inc. ... development and potential commercialization of humanized monoclonal antibodies for ... the company,s website (see here: www.CytoDyn.com ). The ... , 2016, at the LD Micro Invitational in ...
(Date:6/22/2016)... ... 21, 2016 , ... New light-based technologies that facilitate a “look inside” the ... enable both compact, wearable devices for point-of-care diagnostics as well as powerful new systems ... work and visionary future directions are detailed in a new open-access article by Antonio ...
(Date:6/22/2016)... ALBANY, N.Y. , June 22, 2016 ... Molecular Research, Inc. (NASDAQ: AMRI ) ... to produce and sell the first commercially available ... standard is manufactured using Teewinot,s patented biosynthetic processes. ... biosynthetic genes in microorganisms for efficient production of ...
Breaking Biology Technology:
Cached News: