Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615290
First received: January 31, 2008
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: February 3, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: HIV Infections
Intervention: Drug: tipranavir

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aptivus Patients treated by Aptivus in daily practice

Participant Flow:   Overall Study
    Aptivus  
STARTED     42  
COMPLETED     34  
NOT COMPLETED     8  
Adverse Event                 2  
Lost to Follow-up                 3  
Withdrawal by Subject                 1  
unknown                 2  



  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.
All enrolled patients

Reporting Groups
  Description
Aptivus Patients treated by Aptivus in daily practice

Baseline Measures
    Aptivus  
Number of Participants  
[units: participants]
  42  
Age  
[units: Years]
Mean ± Standard Deviation
  43.9  ± 6.6  
Gender  
[units: participants]
 
Female     8  
Male     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3   [ Time Frame: 6 months after inclusion ]

2.  Secondary:   Evaluation of Early Virological Response   [ Time Frame: 1 month after inclusion ]

3.  Secondary:   Viral Load Response at 1 Month   [ Time Frame: 1 month after inclusion ]

4.  Secondary:   CD4 Count at 1 Month   [ Time Frame: 1 month after inclusion ]

5.  Secondary:   Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL   [ Time Frame: 3 months after inclusion ]

6.  Secondary:   Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL   [ Time Frame: 3 months after inclusion ]

7.  Secondary:   Viral Load Response at 3 Months   [ Time Frame: 3 months after inclusion ]

8.  Secondary:   CD4 Count at 3 Months   [ Time Frame: 3 months after inclusion ]

9.  Secondary:   Patient Self Perception of the New Treatment   [ Time Frame: Day 0, month 3 and month 6 ]


  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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615290     History of Changes
Other Study ID Numbers: 1182.127
Study First Received: January 31, 2008
Results First Received: February 3, 2010
Last Updated: February 24, 2014
Health Authority: France: Comite consultatif sur le traitement de l'information en matiere de recherche dans le domaine de la sante (CCTIRS)