Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00531206
First received: September 17, 2007
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: January 28, 2010  
Study Type: Observational
Study Design: 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
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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® in Combination With Low-dose Norvir® Aptivus® in combination with low-dose Norvir® and optimised backbone therapy

Participant Flow:   Overall Study
    Aptivus® in Combination With Low-dose Norvir®  
STARTED     65  
COMPLETED     45  
NOT COMPLETED     20  
Adverse Event related                 5  
Lack of Efficacy                 2  
Lost to Follow-up                 5  
including non-related adverse events                 8  



  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
Aptivus® in Combination With Low-dose Norvir® Aptivus® in combination with low-dose Norvir® and optimised backbone therapy

Baseline Measures
    Aptivus® in Combination With Low-dose Norvir®  
Number of Participants  
[units: participants]
  65  
Age  
[units: Years]
Mean ± Standard Deviation
  45.9  ± 8.8  
Gender  
[units: participants]
 
Female     6  
Male     59  



  Outcome Measures
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1.  Primary:   Adverse Events   [ Time Frame: 52 weeks ]

2.  Secondary:   Change in Viral Load   [ Time Frame: Baseline and 52 weeks ]

3.  Secondary:   CD4+ Cell Count   [ Time Frame: Baseline and 52 weeks ]

4.  Secondary:   Subjective Well-being   [ Time Frame: 52 weeks ]

5.  Secondary:   Serious Adverse Events   [ Time Frame: 52 weeks ]

6.  Secondary:   Deaths   [ Time Frame: 52 weeks ]

7.  Secondary:   Discontinuations Due to an Adverse Event   [ Time Frame: 52 weeks ]

8.  Secondary:   Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion   [ Time Frame: 52 weeks ]

9.  Secondary:   Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir   [ Time Frame: 52 weeks ]

10.  Secondary:   Use of Lipid Lowering Agents During the Study   [ Time Frame: 52 weeks ]

11.  Secondary:   Body Mass Index Class (Kilograms/Square Meter)   [ Time Frame: 52 weeks ]

12.  Secondary:   Total Cholesterol Over Time   [ Time Frame: 52 weeks ]

13.  Secondary:   High Density Lipoprotein (HDL) Cholesterol Over Time   [ Time Frame: 52 weeks ]

14.  Secondary:   Low Density Lipoprotein (HDL) Cholesterol Over Time   [ Time Frame: 52 weeks ]

15.  Secondary:   Triglycerides Over Time   [ Time Frame: 52 weeks ]

16.  Secondary:   Alanine Aminotransferase (ALT) Over Time   [ Time Frame: 52 weeks ]

17.  Secondary:   Aspartate Aminotransferase (ALT) Over Time   [ Time Frame: 52 weeks ]

18.  Secondary:   Gamma-glutamyl Transpeptidase (GGT) Over Time   [ Time Frame: 52 weeks ]

19.  Secondary:   Creatinine Over Time   [ Time Frame: 52 weeks ]

20.  Secondary:   Total Bilirubin Over Time   [ Time Frame: 52 weeks ]

21.  Secondary:   Alkaline Phosphatase Over Time   [ Time Frame: 52 weeks ]


  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: NCT00531206     History of Changes
Other Study ID Numbers: 1182.112
Study First Received: September 17, 2007
Results First Received: January 28, 2010
Last Updated: February 24, 2014
Health Authority: Germany: