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Tipranavir 500/100 & 500/200 vs Kaletra in Naives
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Reported by Jules Levin
8th Intl Congress on Drug Therapy in HIV
Glasgow, UK, Nov 16, 2006
"Efficacy and safety of two doses of tipranavir/r versus lopinavir/r based therapy in antiretroviral naïve patients: results of BI1182.33 trial"
David Cooper on behalf of the BI1182.33 investigators
AUTHOR CONCLUSIONS
Post-hoc efficacy analysis performed after all patients had completed Week 60 visit: the 500 mg/200 mg BID dose was non-inferior to LPV/r. However, the 500 mg/100 mg BID dose was not non-inferior.
The two TPV/r doses tested were effective in treatment naïve patients:
-- Similar percentage of patients reaching VL <50 copies/mL at Week 48 in both arms
-- Similar increase in CD4+ cells in both arms
Increased rate of Grade 3/4 ALT/AST levels in patients receiving 500 mg/200 mg BID compared with other arms; dose not suitable for HIV treatment naïve patients with WT virus .
Grade 3/4 lipid elevations and transaminase elevations in TPV/r 500 mg/100 mg BID were comparable to those in LPV/r recipients.
Trial design
Open-label, randomized, international, parallel group, non-inferiority trial.
Primary Endpoint: percentage of treatment responders (VL <50 cp/ml) at week 48.
Demographic Baseline Data
Average CD4 was about 200 and viral load about 100,000 c/ml About 50% had >100,000 c/ml.
Results: Week 48 analysis
Disposition at Week 48
*3 patients randomized to receive TPV/r-100 received TPV/2-200.
15 patients in all three arms had their first VL <50 copies/mL at Week 48. First opportunity for these patients to have confirmed VL <50 copies/mL was at Week 60.
For this reason, a Week 48 analysis including Week 60 data from all patients was conducted.
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