3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects|
- Virologic response after 2 weeks of functional monotherapy
- Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
|Study Start Date:||March 2002|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
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|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Pharmaceuticals|