ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00517192
Recruitment Status : Terminated
First Posted : August 16, 2007
Results First Posted : October 23, 2009
Last Update Posted : May 14, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tipranavir
Drug: Darunavir
Drug: Ritonavir

  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
No text entered.

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

Participant Flow:   Overall Study
    Tipranavir 500 mg/Ritonavir 200 mg   Darunavir 600 mg/Ritonavir 100 mg
STARTED   19   20 
COMPLETED   0   0 
NOT COMPLETED   19   20 
Adverse Event                1                1 
Lost to Follow-up                1                1 
Withdrawal by Subject                1                0 
Early termination of the trial                16                18 



  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.
No text entered.

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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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

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

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

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

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

Measure Type Secondary
Measure Title Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
Measure Description No text entered.
Time Frame up to 48 weeks  

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 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

Measured Values
   Tipranavir 500 mg/Ritonavir 200 mg   Darunavir 600 mg/Ritonavir 100 mg 
Participants Analyzed 
[Units: Participants]
 		 0   0 
Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF       

No statistical analysis provided for Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF



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

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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

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

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

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

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

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

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

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

22.  Secondary:   Occurrence of New AIDS Progression Events or Death   [ Time Frame: through 48 weeks of treatment ]
  Show Outcome Measure 22


  Serious Adverse Events


  Other Adverse Events


  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