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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.
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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 
Overall Participants Analyzed 
[Units: Participants]
 435   428   863 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 42.5  (8.4)   42.9  (8)   42.7  (8.2) 
[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.
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 ]

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
  Hide Other Adverse Events

Time Frame 240 weeks
Additional Description 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.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Tipranavir(TPV)/Low Dose Ritonavir(r)   Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)
Total, other (not including serious) adverse events     
# participants affected / at risk   359/438 (81.96%)   270/428 (63.08%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   50/438 (11.42%)   29/428 (6.78%) 
Abdominal pain upper † 1     
# participants affected / at risk   35/438 (7.99%)   25/428 (5.84%) 
Diarrhoea † 1     
# participants affected / at risk   148/438 (33.79%)   100/428 (23.36%) 
Dyspepsia † 1     
# participants affected / at risk   27/438 (6.16%)   18/428 (4.21%) 
Flatulence † 1     
# participants affected / at risk   27/438 (6.16%)   18/428 (4.21%) 
Nausea † 1     
# participants affected / at risk   87/438 (19.86%)   42/428 (9.81%) 
Vomiting † 1     
# participants affected / at risk   57/438 (13.01%)   34/428 (7.94%) 
General disorders     
Adverse drug reaction † 1     
# participants affected / at risk   22/438 (5.02%)   2/428 (0.47%) 
Asthenia † 1     
# participants affected / at risk   34/438 (7.76%)   26/428 (6.07%) 
Fatigue † 1     
# participants affected / at risk   39/438 (8.90%)   24/428 (5.61%) 
Pyrexia † 1     
# participants affected / at risk   65/438 (14.84%)   39/428 (9.11%) 
Infections and infestations     
Bronchitis † 1     
# participants affected / at risk   58/438 (13.24%)   23/428 (5.37%) 
Influenza † 1     
# participants affected / at risk   48/438 (10.96%)   35/428 (8.18%) 
Nasopharyngitis † 1     
# participants affected / at risk   74/438 (16.89%)   38/428 (8.88%) 
Oral candidiasis † 1     
# participants affected / at risk   42/438 (9.59%)   31/428 (7.24%) 
Sinusitis † 1     
# participants affected / at risk   36/438 (8.22%)   16/428 (3.74%) 
Urinary tract infection † 1     
# participants affected / at risk   26/438 (5.94%)   6/428 (1.40%) 
Investigations     
Weight decreased † 1     
# participants affected / at risk   32/438 (7.31%)   14/428 (3.27%) 
Metabolism and nutrition disorders     
Hypertriglyceridaemia † 1     
# participants affected / at risk   32/438 (7.31%)   20/428 (4.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   24/438 (5.48%)   20/428 (4.67%) 
Back pain † 1     
# participants affected / at risk   38/438 (8.68%)   17/428 (3.97%) 
Myalgia † 1     
# participants affected / at risk   26/438 (5.94%)   19/428 (4.44%) 
Pain in extremity † 1     
# participants affected / at risk   24/438 (5.48%)   13/428 (3.04%) 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   39/438 (8.90%)   15/428 (3.50%) 
Headache † 1     
# participants affected / at risk   78/438 (17.81%)   34/428 (7.94%) 
Psychiatric disorders     
Depression † 1     
# participants affected / at risk   31/438 (7.08%)   14/428 (3.27%) 
Insomnia † 1     
# participants affected / at risk   27/438 (6.16%)   26/428 (6.07%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   47/438 (10.73%)   28/428 (6.54%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1     
# participants affected / at risk   33/438 (7.53%)   16/428 (3.74%) 
Rash † 1     
# participants affected / at risk   36/438 (8.22%)   23/428 (5.37%) 
Events were collected by systematic assessment
1 Term from vocabulary, MEDDRA 11.1



  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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