CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 997 enrolled
Drug / intervention
Tipranavirdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Prior successful completion of a combination tipranavir/ritonavir trial OR confirmed virologic failure in trials 1182.12 or 1182.48 with inability to obtain TPV by prescription
  • ✓Documented HIV-1 infection confirmed by ELISA and Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or second antibody test by non-ELISA method
  • ✓Age 18 years and older
  • ✓Demonstrated adherence to previous tipranavir/ritonavir dosing protocol and visit requirements as assessed by principal investigator
Key exclusion· 6
  • ✕Active use of investigational HIV-1 vaccines or new investigational antiretroviral agents not approved in prior tipranavir trial
  • ✕Active injection drug use or other substance abuse (extensive alcohol or narcotic use) deemed significant impairment to health and protocol adherence
  • ✕Active HIV-related or non-HIV-related illness that may be negatively affected by tipranavir/ritonavir use
  • ✕Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values

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

Search/NCT00146328
NCT00146328Phase 3Completed
CompareCT.gov

A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects

Boehringer Ingelheim·interventional·Posted Sep 7, 2005·Updated Mar 6, 2014

In Brief

A Phase 3 clinical trial evaluating Tipranavir for HIV Infections. Completed, enrolled 997 participants across 233 sites in 18 countries.

Detailed Summary

The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.

Study Details

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

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartApr 1, 2001
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 20.8 years ago

Interventions

Tipranavirdrug