Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

Summary

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

Timeline

Start

2003-01

Primary completion

2008-09

Completion

—

Outcome

Met primary endpoint

registry NUMBER Tipranavir(TPV)/Low Dose Ritonavir(r): 33.80 percentage of participants NCT00054717 ↗

registry analysis (superiority or other test); Tipranavir(TPV)/Low Dose Ritonavir(r) vs Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r); p = 0.0001; Cochran-Mantel-Haenszel NCT00054717 ↗

registry MEDIAN Tipranavir(TPV)/Low Dose Ritonavir(r): 113 (0 to 395) Days NCT00054717 ↗

registry analysis (superiority or other test); Tipranavir(TPV)/Low Dose Ritonavir(r) vs Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r); p = 0.0001; Log Rank NCT00054717 ↗

Publications

• Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75. doi: 10.1016/S0140-6736(06)69154-X.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tipranavir	Small molecule	—	—
Background	Ritonavir	Other / unclassified	—	—

Indications