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Completed

NCT Number: NCT00054717

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1182.12.1401 St. Vincent's Hospital, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients meeting the following criteria will be eligible for participation in th is study:

  • Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
  • 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.

  • 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.
  • 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:

  • Antiretroviral (ARV) medication naïve.
  • Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
  • 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.

Treatment and study plan

Tipranavir

Drug

Ritonavir(r)

Drug

Comparator Protease Inhibitor (CPI)

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2008
First posted
Feb 10, 2003
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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