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.
|ClinicalTrials.gov Identifier: NCT00144105|
Recruitment Status : Terminated
First Posted : September 5, 2005
Last Update Posted : November 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: TPV500mg/RTV200mgBID Drug: TPV500mg/RTV100mgBID Drug: LPV400mg/RTV100mgBID||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||562 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||November 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144105
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|OverallOfficial:||Boehringer Ingelheim Study Coordinator|