| February 7, 2003 |
| May 28, 2009 |
| January 2003 |
| September 2008 (final data collection date for primary outcome measure) |
| The primary endpoints are the proportion of patients with a treatment response at 48 weeks (>=1 log10 reduction in two consecutive viral load measurements without prior evidence of treatment failure) and the time to treatment failure through 48 weeks. [ Time Frame: 48 weeks ] |
| The primary endpoints are the proportion of patients with a treatment response at 48 weeks (>=1 log10 reduction in two consecutive viral load measurements without prior evidence of treatment failure) and the time to treatment failure through 48 weeks. |
| Complete list of historical versions of study NCT00054717 on ClinicalTrials.gov Archive Site |
| Treatment emergent AIDS-defining illnesses reported in the first 48 weeks of study treatment. [ Time Frame: 24 weeks ] |
| Treatment emergent AIDS-defining illnesses reported in the first 48 weeks of study treatment. |
| |
| Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST) |
| 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. |
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced HIV-1 infected patients. |
| |
| Phase III |
| Interventional |
| Treatment, Parallel Assignment, Safety/Efficacy Study |
| HIV Infections |
| Drug: Tipranavir/Ritonavir |
| |
| 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. |
| |
| Completed |
| 630 |
|
| September 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Patients meeting the following criteria will be eligible for participation in this study:
- HIV-1 infected males or females >=18 years of age.
- Screening genotypic resistance report indicating both of the following: at least one primary PI mutation at the following sites: 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.
- At least 3 consecutive months experience taking ARVs from each of the classes of NRTI(s), NNRTI(s), and PIs at some point in treatment history,with at least 2 PI-based regimens, one of which must be the current regimen, and current PI-based ARV medication regimen for at least 3 months prior to randomization.
- HIV-1 viral load >=1,000 copies/mL at screening.
Exclusion Criteria:
Patients with any of the following criteria are excluded from participation in the study:
- ARV medication naïve.
- Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
- ALT >=3.0x ULN and AST >=2.5x ULN (>=DAIDS Grade 1) at either screening visit.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Canada, Puerto Rico |
| |
| NCT00054717 |
| Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| 1182.12 |
| Boehringer Ingelheim Pharmaceuticals |
|
| Study Chair: |
Boehringer Ingelheim |
Boehringer Ingelheim Pharmaceuticals |
|
|
| Boehringer Ingelheim Pharmaceuticals |
| May 2009 |
