Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144170
First received: September 2, 2005
Last updated: June 23, 2014
Last verified: April 2014
Results First Received: September 11, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tipranavir (with low dose ritonavir)
Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Participant Flow:   Overall Study
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
STARTED     438     428  
COMPLETED     86     32  
NOT COMPLETED     352     396  
Adverse Event                 84                 41  
Protocol Violation                 23                 16  
Lost to Follow-up                 5                 10  
Withdrawal by Subject                 29                 13  
Other reason not defined above                 211                 316  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.
Total Total of all reporting groups

Baseline Measures
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)     Total  
Number of Participants  
[units: participants]
  435     428     863  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.5  ± 8.4     42.9  ± 8     42.7  ± 8.2  
Gender [1]
[units: participants]
     
Female     84     64     148  
Male     351     364     715  
[1] 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Response at Week 48   [ Time Frame: after 48 weeks of treatment ]

2.  Primary:   Time to Treatment Failure Through 48 Weeks of Treatment   [ Time Frame: after 48 weeks of treatment ]

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

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

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

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

7.  Secondary:   Treatment Response at Week 24   [ Time Frame: Week 24 ]

8.  Secondary:   Treatment Response at Week 32   [ Time Frame: week 32 ]

9.  Secondary:   Treatment Response at Week 40   [ Time Frame: week 40 ]

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

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

12.  Secondary:   Treatment Response at Week 72   [ Time Frame: week 72 ]

13.  Secondary:   Treatment Response at Week 80   [ Time Frame: week 80 ]

14.  Secondary:   Treatment Response at Week 88   [ Time Frame: week 88 ]

15.  Secondary:   Treatment Response at Week 96   [ Time Frame: after 96 weeks of treatment ]

16.  Secondary:   Time to Treatment Failure Through 96 Weeks of Treatment   [ Time Frame: after 96 weeks of treatment ]

17.  Secondary:   Time to Confirmed Virologic Failure Through 48 Weeks of Treatment   [ Time Frame: after 48 weeks of treatment ]

18.  Secondary:   Time to Confirmed Virologic Failure Through 96 Weeks of Treatment   [ Time Frame: after 96 weeks of treatment ]

19.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

20.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

21.  Secondary:   Virologic Response at Week 4   [ Time Frame: week 4 ]

22.  Secondary:   Virologic Response at Week 8   [ Time Frame: week 8 ]

23.  Secondary:   Virologic Response at Week 16   [ Time Frame: week 16 ]

24.  Secondary:   Virologic Response at Week 24   [ Time Frame: week 24 ]

25.  Secondary:   Virologic Response at Week 32   [ Time Frame: week 32 ]

26.  Secondary:   Virologic Response at Week 40   [ Time Frame: week 40 ]

27.  Secondary:   Virologic Response at Week 48   [ Time Frame: week 48 ]

28.  Secondary:   Virologic Response at Week 56   [ Time Frame: week 56 ]

29.  Secondary:   Virologic Response at Week 64   [ Time Frame: week 64 ]

30.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]
  Hide Outcome Measure 30

Measure Type Secondary
Measure Title Virologic Response at Week 72
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 72  
[units: Percentage¬†of¬†participants]
  32.2     13.8  

No statistical analysis provided for Virologic Response at Week 72



31.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

32.  Secondary:   Virologic Response at Week 88   [ Time Frame: Week 88 ]

33.  Secondary:   Virologic Response at Week 96   [ Time Frame: Week 96 ]

34.  Secondary:   Median Change From Baseline in Viral Load (Week 2)   [ Time Frame: Baseline to Week 2 ]

35.  Secondary:   Median Change From Baseline in Viral Load (Week 4)   [ Time Frame: Baseline to Week 4 ]

36.  Secondary:   Median Change From Baseline in Viral Load (Week 8)   [ Time Frame: Baseline to Week 8 ]

37.  Secondary:   Median Change From Baseline in Viral Load (Week 16)   [ Time Frame: Baseline to Week 16 ]

38.  Secondary:   Median Change From Baseline in Viral Load (Week 24)   [ Time Frame: Baseline to Week 24 ]

39.  Secondary:   Median Change From Baseline in Viral Load (Week 32)   [ Time Frame: Baseline to Week 32 ]

40.  Secondary:   Median Change From Baseline in Viral Load (Week 40)   [ Time Frame: Baseline to Week 40 ]

41.  Secondary:   Median Change From Baseline in Viral Load (Week 48)   [ Time Frame: Baseline to Week 48 ]

42.  Secondary:   Median Change From Baseline in Viral Load (Week 56)   [ Time Frame: Baseline to Week 56 ]

43.  Secondary:   Median Change From Baseline in Viral Load (Week 64)   [ Time Frame: Baseline to Week 64 ]

44.  Secondary:   Median Change From Baseline in Viral Load (Week 72)   [ Time Frame: Baseline to Week 72 ]

45.  Secondary:   Median Change From Baseline in Viral Load (Week 80)   [ Time Frame: Baseline to Week 80 ]

46.  Secondary:   Median Change From Baseline in Viral Load (Week 88)   [ Time Frame: Baseline to Week 88 ]

47.  Secondary:   Median Change From Baseline in Viral Load (Week 96)   [ Time Frame: Baseline to Week 96 ]

48.  Secondary:   Virologic Response at Week 40   [ Time Frame: Week 40 ]

49.  Secondary:   Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

50.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

51.  Secondary:   Virologic Response at Week 4   [ Time Frame: Week 4 ]

52.  Secondary:   Virologic Response at Week 8   [ Time Frame: Week 8 ]

53.  Secondary:   Virologic Response at Week 16   [ Time Frame: Week 16 ]

54.  Secondary:   Virologic Response at Week 24   [ Time Frame: Week 24 ]

55.  Secondary:   Virologic Response at Week 32   [ Time Frame: Week 32 ]

56.  Secondary:   Virologic Response at Week 48   [ Time Frame: Week 48 ]

57.  Secondary:   Virologic Response at Week 56   [ Time Frame: Week 56 ]

58.  Secondary:   Virologic Response at Week 64   [ Time Frame: Week 64 ]

59.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

60.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

61.  Secondary:   Virologic Response at Week 88   [ Time Frame: week 88 ]

62.  Secondary:   Virologic Response at Week 96   [ Time Frame: week 96 ]

63.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

64.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

65.  Secondary:   Virologic Response at Week 4   [ Time Frame: Week 4 ]

66.  Secondary:   Virologic Response at Week 8   [ Time Frame: Week 8 ]

67.  Secondary:   Virologic Response at Week 16   [ Time Frame: Week 16 ]

68.  Secondary:   Virologic Response at Week 24   [ Time Frame: Week 24 ]

69.  Secondary:   Virologic Response at Week 32   [ Time Frame: Week 32 ]

70.  Secondary:   Virologic Response at Week 40   [ Time Frame: Week 40 ]

71.  Secondary:   Virologic Response at Week 48   [ Time Frame: Week 48 ]

72.  Secondary:   Virologic Response at Week 56   [ Time Frame: Week 56 ]

73.  Secondary:   Virologic Response at Week 64   [ Time Frame: Week 64 ]

74.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

75.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

76.  Secondary:   Virologic Response at Week 88   [ Time Frame: Week 88 ]

77.  Secondary:   Virologic Response at Week 96   [ Time Frame: Week 96 ]

78.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 2)   [ Time Frame: Baseline to Week 2 ]

79.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 4)   [ Time Frame: Baseline to Week 4 ]

80.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 8)   [ Time Frame: Baseline to Week 8 ]

81.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 16)   [ Time Frame: Baseline to Week 16 ]

82.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 24)   [ Time Frame: Baseline to Week 24 ]

83.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 32)   [ Time Frame: Baseline to Week 32 ]

84.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 40)   [ Time Frame: Baseline to Week 40 ]

85.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 48)   [ Time Frame: Baseline to Week 48 ]

86.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 56)   [ Time Frame: Baseline to Week 56 ]

87.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 64)   [ Time Frame: Baseline to Week 64 ]

88.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 72)   [ Time Frame: Baseline to Week 72 ]

89.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 80)   [ Time Frame: Baseline to Week 80 ]

90.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 88)   [ Time Frame: Baseline to Week 88 ]

91.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 96)   [ Time Frame: Baseline to Week 96 ]

92.  Secondary:   Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.   [ Time Frame: up to 75 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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