drugset / Trial / NCT00517192

Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

NCT00517192

Phase 3 Terminated 40 enrolled Boehringer Ingelheim
Parallel-groupTreatment

Summary

The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

Timeline

Start
2007-09
Primary completion
2008-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 600 mg
Subject Tipranavir Small molecule 500 mg
Background Ritonavir Other / unclassified 100 mg
Background Ritonavir Other / unclassified 200 mg