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: May 18, 2012
Last verified: May 2012
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: Comparitor protease inhibitor(CPI)/low dose ritonavir(r)

  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
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
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.

Participant Flow:   Overall Study
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor 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  
Lack of Efficacy or Viral load failure                 174                 268  
Investigator decision                 2                 0  
Site closure                 5                 3  
Lost to follow-up or moved                 1                 0  
Patient decision                 1                 3  
Enrolled into other trial                 3                 24  
Half dose of Tipranavir taken                 1                 0  
Not allowed to take Fosamprenavir                 0                 2  
Switch to commercial product                 5                 2  
Viremia                 1                 0  
Started new HIV regimen                 4                 2  
Result of amendment 6                 0                 1  
Last visit not done                 1                 2  
incl./excl. criteria not met                 1                 2  
error of site                 0                 1  
Pregnancy                 4                 0  
missing                 7                 6  
Death                 1                 0  



  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 AEs 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 ]
  Hide Outcome Measure 33

Measure Type Secondary
Measure Title Virologic Response at Week 96
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 96  
Safety Issue  

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.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 96  
[units: Percentage¬†of¬†participants]
  30.1     11.4  

No statistical analysis provided for Virologic Response at 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   [ 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 16)   [ Time Frame: Baseline to Week 16 ]

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


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: NCT00144170     History of Changes
Other Study ID Numbers: 1182.48, RESIST 2
Study First Received: September 2, 2005
Results First Received: September 11, 2009
Last Updated: May 18, 2012
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Bundesministerium fuer soziale Sicherheit und Generationen
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - Milano
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration