A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00976950
First received: September 14, 2009
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: May 30, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections
Interventions: Drug: Tipranavir
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
Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Participant Flow:   Overall Study
    Aptivus and Ritonavir  
STARTED     42  
COMPLETED     36  
NOT COMPLETED     6  
Adverse Event                 3  
Events with no relationship to Aptivus                 3  



  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
Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Baseline Measures
    Aptivus and Ritonavir  
Number of Participants  
[units: participants]
  42  
Age [1]
[units: years]
Mean ± Standard Deviation
  25.5  ± 10.4  
Gender  
[units: Number]
 
Female     19  
Male     23  
Baseline HIV RNA values  
[units: Participants]
 
<= 50 copies/ml     0  
51 - <1,000 copies/ml     1  
1,000 - <10,000 copies/ml     5  
10,000 - <100,000 copies/ml     13  
100,000 - <1,000,000 copies/ml     12  
>= 1,000,000 copies/ml     0  
Missing     11  
Baseline CD4+ count  
[units: Participants]
 
<= 50 cells/mm^3     2  
51 - <251 cells/mm^3     19  
251 - <451 cells/mm^3     13  
>= 451 cells/mm^3     8  
[1] Age is available for 41 patients.



  Outcome Measures
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1.  Primary:   Number of Patients Reporting Adverse Events (AE)   [ Time Frame: 48 weeks ]

2.  Secondary:   Virologic Response   [ Time Frame: 48 weeks ]

3.  Secondary:   Change in CD4+ Cell Count From Baseline at Week 48   [ Time Frame: 48 weeks ]
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Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline at Week 48
Measure Description No text entered.
Time Frame 48 weeks  
Safety Issue No  

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.
Treated set with with non-missing data at the visit

Reporting Groups
  Description
Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Measured Values
    Aptivus and Ritonavir  
Number of Participants Analyzed  
[units: participants]
  28  
Change in CD4+ Cell Count From Baseline at Week 48  
[units: cells/mm^3]
Mean ± Standard Deviation
  85.8  ± 29.6  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline at Week 48




  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 Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00976950     History of Changes
Other Study ID Numbers: 1182.147
Study First Received: September 14, 2009
Results First Received: May 30, 2012
Last Updated: February 24, 2014
Health Authority: Romania: National Medicines Agency