We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00054717
Recruitment Status : Completed
First Posted : February 10, 2003
Results First Posted : November 19, 2009
Last Update Posted : July 2, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tipranavir Drug: Ritonavir(r) Drug: Comparator Protease Inhibitor (CPI) Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2003
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Tipranavir(TPV)/low dose ritonavir(r) Drug: Tipranavir
Drug: Ritonavir(r)
Comparator protease inhibitor(CPI)/low dose ritonavir(r) Drug: Ritonavir(r)
Drug: Comparator Protease Inhibitor (CPI)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Treatment Response at Week 48 [ Time Frame: At week 48 ]
    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

  2. Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]
    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.


Secondary Outcome Measures :
  1. Treatment Response at Week 24 [ Time Frame: Week 24 ]
    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

  2. Treatment Response at Week 2 [ Time Frame: week 2 ]
    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

  3. Treatment Response at Week 4 [ Time Frame: week 4 ]
    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

  4. Treatment Response at Week 8 [ Time Frame: week 8 ]
    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

  5. Treatment Response at Week 16 [ Time Frame: week 16 ]
    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

  6. Treatment Response at Week 32 [ Time Frame: Week 32 ]
    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

  7. Treatment Response at Week 40 [ Time Frame: Week 40 ]
    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

  8. Treatment Response at Week 48 [ Time Frame: Week 48 ]
    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

  9. Treatment Response at Week 56 [ Time Frame: week 56 ]
    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

  10. Treatment Response at Week 64 [ Time Frame: week 64 ]
    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

  11. Treatment Response at Week 72 [ Time Frame: Week 72 ]
    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

  12. Treatment Response at Week 80 [ Time Frame: Week 80 ]
    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

  13. Treatment Response at Week 88 [ Time Frame: Week 88 ]
    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

  14. Treatment Response at Week 96 [ Time Frame: Week 96 ]
    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

  15. Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]
    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.

  16. Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]
    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.

  17. Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]
    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.

  18. Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  19. Virologic Response (Viral Load >= 1 Log Drop) at Week 2 [ Time Frame: Week 2 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  20. Virologic Response (Viral Load >= 1 Log Drop) at Week 4 [ Time Frame: Week 4 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  21. Virologic Response (Viral Load >= 1 Log Drop) at Week 8 [ Time Frame: Week 8 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  22. Virologic Response (Viral Load >= 1 Log Drop) at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  23. Virologic Response (Viral Load >= 1 Log Drop) at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  24. Virologic Response (Viral Load >= 1 Log Drop) at Week 32 [ Time Frame: Week 32 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  25. Virologic Response (Viral Load >= 1 Log Drop) at Week 40 [ Time Frame: Week 40 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  26. Virologic Response (Viral Load >= 1 Log Drop) at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  27. Virologic Response (Viral Load >= 1 Log Drop) at Week 56 [ Time Frame: Week 56 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  28. Virologic Response (Viral Load >= 1 Log Drop) at Week 64 [ Time Frame: Week 64 ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  29. Median Change From Baseline in Viral Load to Week 2 [ Time Frame: Baseline to Week 2 ]
  30. Median Change From Baseline in Viral Load to Week 4 [ Time Frame: Baseline to Week 4 ]
  31. Median Change From Baseline in Viral Load to Week 8 [ Time Frame: Baseline to Week 8 ]
  32. Median Change From Baseline in Viral Load to Week 16 [ Time Frame: Baseline to Week 16 ]
  33. Median Change From Baseline in Viral Load to Week 24 [ Time Frame: Baseline to Week 24 ]
  34. Median Change From Baseline in Viral Load to Week 32 [ Time Frame: Baseline to Week 32 ]
  35. Median Change From Baseline in Viral Load to Week 40 [ Time Frame: Baseline to Week 40 ]
  36. Median Change From Baseline in Viral Load to Week 48 [ Time Frame: Baseline to Week 48 ]
  37. Median Change From Baseline in Viral Load to Week 56 [ Time Frame: Baseline to Week 56 ]
  38. Median Change From Baseline in Viral Load to Week 64 [ Time Frame: Baseline to Week 64 ]
  39. Median Change From Baseline in Viral Load to Week 72 [ Time Frame: Baseline to Week 72 ]
  40. Median Change From Baseline in Viral Load to Week 80 [ Time Frame: Baseline to Week 80 ]
  41. Median Change From Baseline in Viral Load to Week 88 [ Time Frame: Baseline to Week 88 ]
  42. Median Change From Baseline in Viral Load to Week 96 [ Time Frame: Baseline to Week 96 ]
  43. Mean Change From Baseline to Week 2 in CD4+ Cell Count [ Time Frame: Baseline to Week 2 ]
  44. Mean Change From Baseline to Week 4 in CD4+ Cell Count [ Time Frame: Baseline to Week 4 ]
  45. Mean Change From Baseline to Week 8 in CD4+ Cell Count [ Time Frame: Baseline to Week 8 ]
  46. Mean Change From Baseline to Week 16 in CD4+ Cell Count [ Time Frame: Baseline to Week 16 ]
  47. Mean Change From Baseline to Week 24 in CD4+ Cell Count [ Time Frame: Baseline to Week 24 ]
  48. Mean Change From Baseline to Week 32 in CD4+ Cell Count [ Time Frame: Baseline to Week 32 ]
  49. Mean Change From Baseline to Week 40 in CD4+ Cell Count [ Time Frame: Baseline to Week 40 ]
  50. Mean Change From Baseline to Week 48 in CD4+ Cell Count [ Time Frame: Baseline to Week 48 ]
  51. Mean Change From Baseline to Week 56 in CD4+ Cell Count [ Time Frame: Baseline to Week 56 ]
  52. Mean Change From Baseline to Week 64 in CD4+ Cell Count [ Time Frame: Baseline to Week 64 ]
  53. Mean Change From Baseline to Week 72 in CD4+ Cell Count [ Time Frame: Baseline to Week 72 ]
  54. Mean Change From Baseline to Week 80 in CD4+ Cell Count [ Time Frame: Baseline to Week 80 ]
  55. Mean Change From Baseline to Week 88 in CD4+ Cell Count [ Time Frame: Baseline to Week 88 ]
  56. Mean Change From Baseline to Week 96 in CD4+ Cell Count [ Time Frame: Baseline to Week 96 ]
  57. Time to New CDC Class C Progression Event or Death. [ Time Frame: after 48 weeks of treatment ]
    Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death

  58. Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ]
    Percentage of participants with Viral Load < 400 copies/mL

  59. Virologic Response (VL < 400 Copies/ml) at Week 2 [ Time Frame: Week 2 ]
    Percentage of participants with Viral Load < 400 copies/mL

  60. Virologic Response (VL < 400 Copies/ml) at Week 4 [ Time Frame: Week 4 ]
    Percentage of participants with Viral Load < 400 copies/mL

  61. Virologic Response (VL < 400 Copies/ml) at Week 8 [ Time Frame: Week 8 ]
    Percentage of participants with Viral Load < 400 copies/mL

  62. Virologic Response (VL < 400 Copies/ml) at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with Viral Load < 400 copies/mL

  63. Virologic Response (VL < 400 Copies/ml) at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with Viral Load < 400 copies/mL

  64. Virologic Response (VL < 400 Copies/ml) at Week 32 [ Time Frame: week 32 ]
    Percentage of participants with Viral Load < 400 copies/mL

  65. Virologic Response (VL < 400 Copies/ml) at Week 40 [ Time Frame: Week 40 ]
    Percentage of participants with Viral Load < 400 copies/mL

  66. Virologic Response (VL < 400 Copies/ml) at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with Viral Load < 400 copies/mL

  67. Virologic Response (VL < 400 Copies/ml) at Week 56 [ Time Frame: Week 56 ]
    Percentage of participants with Viral Load < 400 copies/mL

  68. Virologic Response (VL < 400 Copies/ml) at Week 64 [ Time Frame: Week 64 ]
    Percentage of participants with Viral Load < 400 copies/mL

  69. Virologic Response (VL < 400 Copies/ml) at Week 72 [ Time Frame: Week 72 ]
    Percentage of participants with Viral Load < 400 copies/mL

  70. Virologic Response (VL < 400 Copies/ml) at Week 80 [ Time Frame: Week 80 ]
    Percentage of participants with Viral Load < 400 copies/mL

  71. Virologic Response (VL < 400 Copies/ml) at Week 88 [ Time Frame: week 88 ]
    Percentage of participants with Viral Load < 400 copies/mL

  72. Virologic Response (VL < 400 Copies/ml) at Week 96 [ Time Frame: week 96 ]
    Percentage of participants with Viral Load < 400 copies/mL

  73. Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ]
    Percentage of participants with Viral Load < 50 copies/mL

  74. Virologic Response (VL < 50 Copies/ml) at Week 2 [ Time Frame: Week 2 ]
    Percentage of participants with Viral Load < 50 copies/mL

  75. Virologic Response (VL < 50 Copies/ml) at Week 4 [ Time Frame: Week 4 ]
    Percentage of participants with Viral Load < 50 copies/mL

  76. Virologic Response (VL < 50 Copies/ml) at Week 8 [ Time Frame: Week 8 ]
    Percentage of participants with Viral Load < 50 copies/mL

  77. Virologic Response (VL < 50 Copies/ml) at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with Viral Load < 50 copies/mL

  78. Virologic Response (VL < 50 Copies/ml) at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with Viral Load < 50 copies/mL

  79. Virologic Response (VL < 50 Copies/ml) at Week 32 [ Time Frame: Week 32 ]
    Percentage of participants with Viral Load < 50 copies/mL

  80. Virologic Response (VL < 50 Copies/ml) at Week 40 [ Time Frame: Week 40 ]
    Percentage of participants with Viral Load < 50 copies/mL

  81. Virologic Response (VL < 50 Copies/ml) at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with Viral Load < 50 copies/mL

  82. Virologic Response (VL < 50 Copies/ml) at Week 56 [ Time Frame: Week 56 ]
    Percentage of participants with Viral Load < 50 copies/mL

  83. Virologic Response (VL < 50 Copies/ml) at Week 64 [ Time Frame: Week 64 ]
    Percentage of participants with Viral Load < 50 copies/mL

  84. Virologic Response (VL < 50 Copies/ml) at Week 72 [ Time Frame: Week 72 ]
    Percentage of participants with Viral Load < 50 copies/mL

  85. Virologic Response (VL < 50 Copies/ml) at Week 80 [ Time Frame: Week 80 ]
    Percentage of participants with Viral Load < 50 copies/mL

  86. Virologic Response (VL < 50 Copies/ml) at Week 88 [ Time Frame: Week 88 ]
    Percentage of participants with Viral Load < 50 copies/mL

  87. Virologic Response (VL < 50 Copies/ml) at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with Viral Load < 50 copies/mL

  88. Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities [ Time Frame: 240 Weeks ]
    NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054717


Locations
Show Show 117 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00054717    
Other Study ID Numbers: 1182.12
First Posted: February 10, 2003    Key Record Dates
Results First Posted: November 19, 2009
Last Update Posted: July 2, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Ritonavir
HIV Protease Inhibitors
Tipranavir
Protease Inhibitors
Viral Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors