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
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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
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
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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 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
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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 ]
  Hide Outcome Measure 13

Measure Type Secondary
Measure Title Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat
Measure Description No text entered.
Time Frame up to 48 weeks  
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 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  
Number of Participants Analyzed  
[units: participants]
  0     0  
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat          

No statistical analysis provided for Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat



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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  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.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Pharmaceuticals
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: NCT00517192     History of Changes
Other Study ID Numbers: 1182.71
Study First Received: August 15, 2007
Results First Received: September 18, 2009
Last Updated: April 25, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada (TPD)
France: AFSSAPS
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authorities for Drugs and Medica
Greece: National Organization for Medicines (EOF) National Ethics Committee
Italy: Comitato Etico Azienda Spedali Civili di Brescia
Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa
Spain: Ministry of Health
Thailand: Ministry of Public Health
United States: Food and Drug Administration