A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
Successfully screened patients are randomised to open label TPV 500 mg with RTV 100 mg or 200 mg BID or open label LPV 400 mg with RTV 100 mg BID. Background ARV therapy is Tenofovir 300 mg + Lamivudine 300 mg QD in all three treatment groups. The randomisation is stratified by CD4 cell count > 200 cells/µL at screening. The duration of the treatment is 156 weeks.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination|
- The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.
- Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||March 2007|
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|Investigator:||Boehringer Ingelheim Study Coordinator|