1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP
October 25 - 29, 2003 Warsaw, Poland
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9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland |
| 7.3 Phase III/IV Trials F1/1 - THE QUAD STUDY: A PILOT-STUDY TO ASSESS THE EFFICACY AND SAFETY OF TRIZIVIR + RTV-BOOSTED SAQUINAVIR (TZV+SQVR) COMPARED TO COMBIVIR + RTV-BOOSTED SAQUINAVIR (CBV+SQVR) IN ART-NAÏVE PATIENTS WITH HIGH VIRAL LOAD (VL) AND LOW CD4 COUNT. 24 WEEK INTERIM ANALYSIS |
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| Staszewski S.1, Stark T.2, Knecht G. (1,3), Mösch M.1, Schlitt C.1, Dauer B.1, Warncke W.4, Walli R.5 |
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| (1) J.W. Goethe University Hospital, HIV Research and Outpatient Center, Frankfurt, Germany,2 GlaxoSmithKline, Greenford, UK,3 Internal Medicine Specialist Center Stresemannallee, Frankfurt, Germany,4 GlaxoSmithKline, Hamburg, Germany,5 GlaxoSmithKline, Munich, Germany |
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Background of Study: Quadruple combination therapy might be an important option for many patients including those with advanced HIV disease.
Objectives: To evaluate the safety and efficacy of the quadruple combination TZV+SQVr and the triple combination CBV+SQVr in ART-naïve patients with advanced HIV disease.
Methods: Randomized, monocentric, open-label study with ART-naïve patients in 2 arms: (i) TZV+SQVr (1000mg/100mg bid); or (ii) CBV+SQVr (1000mg/100mg bid). CD4 count <100/µl and VL >50.000 c/ml were inclusion criteria. Primary endpoint was the proportion of patients with VL <50 c/ml at week 24 (ITT, switch and lost to follow-up = failure).
Results: 59 patients were treated (n=29 TZV; n=30 CBV). Median VL at baseline was 5.45 log10 c/ml (TZV), and 5.47 log10 c/ml (CBV). 27 patients (45% TZV, 47% CBV) were classified as CDC stage C. By week 24, 22/59 patients discontinued their randomized treatment: 15 for drug-related AEs (8 TZV vs. 7 CBV), 7 for non-drug related reasons (3 TZV vs. 4 CBV). No patient discontinued therapy due to virological failure. VL was <50c/ml in 59% of TZV and 50% of CBV patients. Median CD4 count changed from 26/µl to 100/µl and from 34/µl to 190/µl in the two arms respectively. The most common AEs were gastrointestinal (22 TZV; 24 CBV). 4 patients experienced an HSR.
Conclusions: In this pilot study in a very advanced patient population, over 24 weeks, substantial antiviral activity was observed with the quadruple and triple combination therapy. Boths regimens were generally well tolerated.
Presenting Author: Prof. Schlomo Staszewski, JW Goethe University Hospital, HIV research and Outpatient Center, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany, Phone: 0496963017478
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