CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 630 enrolled
Drug / intervention
Tipranavir +2 moredrug
Likely dose
Tipranavir boosted with low-dose ritonavir (TPV/RTV)AI-extracted
Key inclusion· 4
  • ✓HIV-1 infected, aged ≥18 years
  • ✓Genotypic resistance showing at least one primary PI mutation (30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V, or 90M) and no more than two mutations on codons 33, 82, 84, or 90
  • ✓At least 3 months continuous exposure to each of: NRTIs, NNRTIs, and PIs with at least 2 prior PI-based regimens and currently on PI-based regimen for ≥3 months
  • ✓HIV-1 viral load ≥1,000 copies/mL at screening
Key exclusion· 3
  • ✕Antiretroviral naïve patients
  • ✕Off antiretroviral medications for ≥7 consecutive days within the last 3 months
  • ✕ALT ≥3.0× ULN and AST ≥2.5× ULN (≥DAIDS Grade 1) at screening

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

Search/NCT00054717
NCT00054717Phase 3Completed
CompareCT.gov

Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.

Boehringer Ingelheim·interventional·Posted Feb 10, 2003·Updated Jul 2, 2014

In Brief

A Phase 3 clinical trial evaluating Tipranavir, Ritonavir(r), and 1 other intervention for HIV Infections. Completed, enrolled 630 participants across 117 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesAustralia, Canada, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2003
Enrollment StartJan 1, 2003
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 23.4 years ago

Interventions

Tipranavirdrug

Ritonavir(r)drug

Comparator Protease Inhibitor (CPI)drug