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Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
This study has been completed.
Study NCT00054717   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: February 7, 2003   Last Updated: November 2, 2009   History of Changes

February 7, 2003
November 2, 2009
January 2003
September 2008   (final data collection date for primary outcome measure)
  • Treatment Response at Week 48 [ Time Frame: At week 48 ]
  • Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]
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 Response at Week 24 [ Time Frame: Week 24 ]
  • Treatment Response at Week 2 [ Time Frame: week 2 ]
  • Treatment Response at Week 4 [ Time Frame: week 4 ]
  • Treatment Response at Week 8 [ Time Frame: week 8 ]
  • Treatment Response at Week 16 [ Time Frame: week 16 ]
  • Treatment Response at Week 32 [ Time Frame: Week 32 ]
  • Treatment Response at Week 40 [ Time Frame: Week 40 ]
  • Treatment Response at Week 48 [ Time Frame: Week 48 ]
  • Treatment Response at Week 56 [ Time Frame: week 56 ]
  • Treatment Response at Week 64 [ Time Frame: week 64 ]
  • Treatment Response at Week 72 [ Time Frame: Week 72 ]
  • Treatment Response at Week 80 [ Time Frame: Week 80 ]
  • Treatment Response at Week 88 [ Time Frame: Week 88 ]
  • Treatment Response at Week 96 [ Time Frame: Week 96 ]
  • Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]
  • Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]
  • Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]
  • Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]
  • Virologic Response at Week 2 [ Time Frame: Week 2 ]
  • Virologic Response at Week 4 [ Time Frame: Week 4 ]
  • Virologic Response at Week 8 [ Time Frame: Week 8 ]
  • Virologic Response at Week 16 [ Time Frame: Week 16 ]
  • Virologic Response at Week 24 [ Time Frame: Week 24 ]
  • Virologic Response at Week 32 [ Time Frame: Week 32 ]
  • Virologic Response at Week 40 [ Time Frame: Week 40 ]
  • Virologic Response at Week 48 [ Time Frame: Week 48 ]
  • Virologic Response at Week 56 [ Time Frame: Week 56 ]
  • Virologic Response at Week 64 [ Time Frame: Week 64 ]
  • Median Change From Baseline in Viral Load to Week 2 [ Time Frame: Baseline to Week 2 ]
  • Median Change From Baseline in Viral Load to Week 4 [ Time Frame: Baseline to Week 4 ]
  • Median Change From Baseline in Viral Load to Week 8 [ Time Frame: Baseline to Week 8 ]
  • Median Change From Baseline in Viral Load to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Median Change From Baseline in Viral Load to Week 24 [ Time Frame: Baseline to Week 24 ]
  • Median Change From Baseline in Viral Load to Week 32 [ Time Frame: Baseline to Week 32 ]
  • Median Change From Baseline in Viral Load to Week 40 [ Time Frame: Baseline to Week 40 ]
  • Median Change From Baseline in Viral Load to Week 48 [ Time Frame: Baseline to Week 48 ]
  • Median Change From Baseline in Viral Load to Week 56 [ Time Frame: Baseline to Week 56 ]
  • Median Change From Baseline in Viral Load to Week 64 [ Time Frame: Baseline to Week 64 ]
  • Median Change From Baseline in Viral Load to Week 72 [ Time Frame: Baseline to Week 72 ]
  • Median Change From Baseline in Viral Load to Week 80 [ Time Frame: Baseline to Week 80 ]
  • Median Change From Baseline in Viral Load to Week 88 [ Time Frame: Baseline to Week 88 ]
  • Median Change From Baseline in Viral Load to Week 96 [ Time Frame: Baseline to Week 96 ]
  • Mean Change From Baseline to Week 2 in CD4+ Cell Count [ Time Frame: Baseline to Week 2 ]
  • Mean Change From Baseline to Week 4 in CD4+ Cell Count [ Time Frame: Baseline to Week 4 ]
  • Mean Change From Baseline to Week 16 in CD4+ Cell Count [ Time Frame: Baseline to Week 16 ]
  • Mean Change From Baseline to Week 24 in CD4+ Cell Count [ Time Frame: Baseline to Week 24 ]
  • Mean Change From Baseline to Week 32 in CD4+ Cell Count [ Time Frame: Baseline to Week 32 ]
  • Mean Change From Baseline to Week 40 in CD4+ Cell Count [ Time Frame: Baseline to Week 40 ]
  • Mean Change From Baseline to Week 48 in CD4+ Cell Count [ Time Frame: Baseline to Week 48 ]
  • Mean Change From Baseline to Week 56 in CD4+ Cell Count [ Time Frame: Baseline to Week 56 ]
  • Mean Change From Baseline to Week 64 in CD4+ Cell Count [ Time Frame: Baseline to Week 64 ]
  • Mean Change From Baseline to Week 72 in CD4+ Cell Count [ Time Frame: Baseline to Week 72 ]
  • Mean Change From Baseline to Week 80 in CD4+ Cell Count [ Time Frame: Baseline to Week 80 ]
  • Mean Change From Baseline to Week 88 in CD4+ Cell Count [ Time Frame: Baseline to Week 88 ]
  • Mean Change From Baseline to Week 96 in CD4+ Cell Count [ Time Frame: Baseline to Week 96 ]
  • Time to New CDC Class C Progression Event or Death. [ Time Frame: after 48 weeks of treatment ]
  • Virologic Response at Week 72 [ Time Frame: Week 72 ]
  • Virologic Response at Week 80 [ Time Frame: Week 80 ]
  • Virologic Response at Week 88 [ Time Frame: week 88 ]
  • Virologic Response at Week 96 [ Time Frame: week 96 ]
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 Human Immunodeficiency virus 1(HIV-1) infected patients.

 
Phase III
Interventional
Treatment, Parallel Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: Tipranavir
  • Drug: Ritonavir(r)
  • Drug: Comparitor Protease Inhibitor (CPI)
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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 th is study:

  1. Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
  2. Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (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.

3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.

4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.

Exclusion criteria:

Patients with any of the following criteria are excluded from participation in t he study:

  1. Antiretroviral (ARV) medication naïve.
  2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
  3. alanine aminotransferase (ALT) >=3.0x upperlimit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(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
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP