Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: September 9, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tipranavir
Drug: Ritonavir(r)
Drug: Comparator Protease Inhibitor (CPI)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the study there were 630 patients entered as stated in the protocol section. There were 10 patients not treated and are not included within the Participant Flow Module or any other analysis.

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) TPV 500 mg / Ritonavir 200 mg, twice daily
Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)

Participant Flow:   Overall Study
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)  
STARTED     313     317  
COMPLETED     51     18  
NOT COMPLETED     262     299  
Randomized but not treated                 2                 8  
Adverse Event                 70                 22  
Protocol Violation                 18                 19  
Lost to Follow-up                 23                 13  
Withdrawal by Subject                 32                 20  
Other reason not defined above                 117                 217  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Safety Set, all patients treated with at least one dose of study drug

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) TPV 500 mg / Ritonavir 200 mg, twice daily
Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
Total Total of all reporting groups

Baseline Measures
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)     Total  
Number of Participants  
[units: participants]
  311     309     620  
Age  
[units: years]
Mean ± Standard Deviation
  45.6  ± 7.9     44.5  ± 7.1     45.1  ± 7.5  
Gender  
[units: participants]
     
Female     33     22     55  
Male     278     287     565  



  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

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

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

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

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

11.  Secondary:   Treatment Response at Week 48   [ Time Frame: Week 48 ]

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

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

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

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

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

17.  Secondary:   Treatment Response at Week 96   [ Time Frame: Week 96 ]

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

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

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

21.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

22.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 2   [ Time Frame: Week 2 ]

23.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 4   [ Time Frame: Week 4 ]

24.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 8   [ Time Frame: Week 8 ]

25.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 16   [ Time Frame: Week 16 ]

26.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 24   [ Time Frame: Week 24 ]

27.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 32   [ Time Frame: Week 32 ]

28.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 40   [ Time Frame: Week 40 ]

29.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 48   [ Time Frame: Week 48 ]

30.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 56   [ Time Frame: Week 56 ]

31.  Secondary:   Virologic Response (Viral Load >= 1 Log Drop) at Week 64   [ Time Frame: Week 64 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

60.  Secondary:   Time to New CDC Class C Progression Event or Death.   [ Time Frame: after 48 weeks of treatment ]

61.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

62.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 2   [ Time Frame: Week 2 ]

63.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 4   [ Time Frame: Week 4 ]

64.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 8   [ Time Frame: Week 8 ]

65.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 16   [ Time Frame: Week 16 ]

66.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 24   [ Time Frame: Week 24 ]

67.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 32   [ Time Frame: week 32 ]

68.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 40   [ Time Frame: Week 40 ]

69.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 48   [ Time Frame: Week 48 ]

70.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 56   [ Time Frame: Week 56 ]

71.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 64   [ Time Frame: Week 64 ]

72.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 72   [ Time Frame: Week 72 ]

73.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 80   [ Time Frame: Week 80 ]

74.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 88   [ Time Frame: week 88 ]

75.  Secondary:   Virologic Response (VL < 400 Copies/ml) at Week 96   [ Time Frame: week 96 ]

76.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

77.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 2   [ Time Frame: Week 2 ]

78.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 4   [ Time Frame: Week 4 ]

79.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 8   [ Time Frame: Week 8 ]

80.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 16   [ Time Frame: Week 16 ]

81.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 24   [ Time Frame: Week 24 ]

82.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 32   [ Time Frame: Week 32 ]

83.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 40   [ Time Frame: Week 40 ]

84.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 48   [ Time Frame: Week 48 ]

85.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 56   [ Time Frame: Week 56 ]

86.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 64   [ Time Frame: Week 64 ]

87.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 72   [ Time Frame: Week 72 ]

88.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 80   [ Time Frame: Week 80 ]

89.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 88   [ Time Frame: Week 88 ]

90.  Secondary:   Virologic Response (VL < 50 Copies/ml) at Week 96   [ Time Frame: Week 96 ]

91.  Secondary:   Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities   [ Time Frame: 240 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00054717     History of Changes
Other Study ID Numbers: 1182.12
Study First Received: February 7, 2003
Results First Received: September 9, 2009
Last Updated: June 23, 2014
Health Authority: Australia: Responsilble Ethics Committee
Canada: Health Canada (TPD)
United States: Food and Drug Administration