Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00517192
First received: August 15, 2007
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: September 18, 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: Darunavir
Drug: Ritonavir

  Participant Flow


  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 500 mg/Ritonavir 200 mg Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Darunavir 600 mg/Ritonavir 100 mg Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
Total Total of all reporting groups

Baseline Measures
    Tipranavir 500 mg/Ritonavir 200 mg     Darunavir 600 mg/Ritonavir 100 mg     Total  
Number of Participants  
[units: participants]
  19     20     39  
Age  
[units: Years]
Mean ± Standard Deviation
  44.3  ± 6.1     43.1  ± 6.2     43.6  ± 6.1  
Gender  
[units: Number of participants]
     
Female     4     3     7  
Male     15     17     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.   [ Time Frame: 48 weeks of treatment ]

2.  Secondary:   Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).   [ Time Frame: 48 weeks of treatment ]

3.  Secondary:   Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.   [ Time Frame: 48 weeks of treatment ]

4.  Secondary:   Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.   [ Time Frame: 48 weeks of treatment ]

5.  Secondary:   Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored   [ Time Frame: up to 48 weeks ]

6.  Secondary:   Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF   [ Time Frame: up to 48 weeks ]

7.  Secondary:   Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat   [ Time Frame: up to 48 weeks ]

8.  Secondary:   Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored   [ Time Frame: up to 48 weeks ]

9.  Secondary:   Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF   [ Time Frame: up to 48 weeks ]

10.  Secondary:   Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat   [ Time Frame: up to 48 weeks ]

11.  Secondary:   Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored   [ Time Frame: up to 48 weeks ]

12.  Secondary:   Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF   [ Time Frame: up to 48 weeks ]

13.  Secondary:   Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat   [ Time Frame: up to 48 weeks ]

14.  Secondary:   Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8   [ Time Frame: up to week 8 ]

15.  Secondary:   Daily Average in CD4+ Cell Count Change From Baseline up to Week 24   [ Time Frame: up to week 24 ]

16.  Secondary:   Daily Average in CD4+ Cell Count Change From Baseline up to Week 48   [ Time Frame: up to week 48 ]

17.  Secondary:   Daily Average in Viral Load Change From Baseline up to Week 8   [ Time Frame: up to week 8 ]

18.  Secondary:   Daily Average in Viral Load Change From Baseline up to Week 24   [ Time Frame: up to week 24 ]

19.  Secondary:   Daily Average in Viral Load Change From Baseline up to Week 48   [ Time Frame: up to week 48 ]

20.  Secondary:   Change From Baseline in CD4+ Cell Count up to Week 48   [ Time Frame: up to week 48 ]

21.  Secondary:   Change From Baseline in log10 Viral Load up to Week 48   [ Time Frame: up to week 48 ]

22.  Secondary:   Occurrence of New AIDS Progression Events or Death   [ Time Frame: through 48 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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