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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.
ClinicalTrials.gov Identifier:
First Posted: September 15, 2009
Last Update Posted: March 20, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: 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
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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
Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Participant Flow:   Overall Study
    Aptivus and Ritonavir
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.
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Reporting Groups
Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Baseline Measures
   Aptivus and Ritonavir 
Overall Participants Analyzed 
[Units: Participants]
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 25.5  (10.4) 
[1] Age is available for 41 patients.
[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 

  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 ]

  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