Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00054717
First received: February 7, 2003
Last updated: June 23, 2014
Last verified: April 2014

February 7, 2003
June 23, 2014
January 2003
September 2008   (final data collection date for primary outcome measure)
  • Treatment Response at Week 48 [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
Not Provided
Complete list of historical versions of study NCT00054717 on ClinicalTrials.gov Archive Site
  • Treatment Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 56 [ Time Frame: week 56 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 64 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Treatment Response at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
  • Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
  • Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
  • Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
  • Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
  • Median Change From Baseline in Viral Load to Week 2 [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 4 [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 32 [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 40 [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 56 [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 64 [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 80 [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 88 [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 96 [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 2 in CD4+ Cell Count [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 4 in CD4+ Cell Count [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 8 in CD4+ Cell Count [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 16 in CD4+ Cell Count [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 24 in CD4+ Cell Count [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 32 in CD4+ Cell Count [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 40 in CD4+ Cell Count [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 48 in CD4+ Cell Count [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 56 in CD4+ Cell Count [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 64 in CD4+ Cell Count [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 72 in CD4+ Cell Count [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 80 in CD4+ Cell Count [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 88 in CD4+ Cell Count [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 96 in CD4+ Cell Count [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Time to New CDC Class C Progression Event or Death. [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death
  • Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 32 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 400 Copies/ml) at Week 96 [ Time Frame: week 96 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Virologic Response (VL < 50 Copies/ml) at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL
  • Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities [ Time Frame: 240 Weeks ] [ Designated as safety issue: No ]
    NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Tipranavir
  • Drug: Ritonavir(r)
  • Drug: Comparator Protease Inhibitor (CPI)
  • Tipranavir(TPV)/low dose ritonavir(r)
    Interventions:
    • Drug: Tipranavir
    • Drug: Ritonavir(r)
  • Comparator protease inhibitor(CPI)/low dose ritonavir(r)
    Interventions:
    • Drug: Ritonavir(r)
    • Drug: Comparator 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
Not Provided
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 upper limit 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
1182.12
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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