CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 882 enrolled
Drug / intervention
Tipranavir (with low dose ritonavir) +1 moredrug
Likely dose
Tipranavir boosted with low-dose ritonavirAI-extracted
Key inclusion· 8
  • ✓Age ≥18 years with HIV-1 infection
  • ✓Screening genotype showing at least one primary protease mutation at positions 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V, or 90M
  • ✓No more than two protease mutations at codons 33, 82, 84, or 90
  • ✓At least 3 consecutive months of NRTI, NNRTI, and PI exposure at some point in treatment history
Key exclusion· 7
  • ✕Antiretroviral treatment-naïve patients
  • ✕Off antiretroviral medications for ≥7 consecutive days within the last 3 months
  • ✕Prior tipranavir use
  • ✕Investigational medications within 30 days before study entry (except T-20 and Tenofovir)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00144170
NCT00144170Phase 3Completed
CompareCT.gov

Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)

Boehringer Ingelheim·interventional·Posted Sep 5, 2005·Updated Jul 2, 2014

In Brief

A Phase 3 clinical trial evaluating Tipranavir (with low dose ritonavir) and Comparator protease inhibitor(CPI)/low dose ritonavir(r) for HIV Infections. Completed, enrolled 882 participants across 174 sites in 17 countries.

Detailed Summary

The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Austria, Belgium, Brazil, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartFeb 1, 2003
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.8 years ago

Interventions

Tipranavir (with low dose ritonavir)drug

Comparator protease inhibitor(CPI)/low dose ritonavir(r)drug