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:12/2/2016)... Dec. 1, 2016   SoftServe , a ... BioLock , an electrocardiogram (ECG) biosensor analysis system ... key IoT asset. The smart system ensures device-to-device ... steering wheel and mobile devices to easily ,recognize, ... As vehicle technology advances, so too must ...
(Date:11/30/2016)... 30, 2016  higi SH llc (higi) announced ... targeting national brands, industry thought-leaders and celebrity influencers ... audiences for taking steps to live healthier, more ... 2012, higi has built the largest self-screening health ... million people who have conducted over 185 million ...
(Date:11/29/2016)... Nov. 29, 2016   Neurotechnology , ... object recognition technologies, today released FingerCell 3.0, ... recognition solutions that run on low-power, low-memory ... using less than 128KB of memory, enabling ... that have limited on-board resources, such as: ...
Breaking Biology News(10 mins):
(Date:12/8/2016)... 8, 2016  Anaconda BioMed S.L., a pre-clinical stage ... next generation neuro-thrombectomy system for the treatment of Acute ... Jovin, MD to join its Scientific Advisory Board (SAB). ... network of scientific and clinical experts to Anaconda BioMed ... ANCD BRAIN ® to its clinical phase. The ...
(Date:12/8/2016)... ... , ... This CAST literature review and report looks at problems caused by ... economic effects in countries that are major global commodity exporters and importers, which show ... of low level presence (LLP) puts large volumes of trade worth billions of dollars ...
(Date:12/8/2016)... Dec. 8, 2016 Savannah River Remediation ... and selected NewTechBio,s NT-MAX Lake & Pond ... beneficial bacteria, in conjunction with Hexa Armor/ Rhombo ... with National Pollutant Discharge Elimination System requirements. ... a steady history of elevated pH levels, above ...
(Date:12/7/2016)... ... December 07, 2016 , ... ACEA ... dose escalation and expansion clinical trial for its lead drug candidate, AC0010, at ... of the trial was to determine the safety, antitumor activity, and recommended phase ...
Breaking Biology Technology:
Cached News: