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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976950
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
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 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 25.5  (10.4) 
[1] Age is available for 41 patients.
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 


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

Measure Type Primary
Measure Title Number of Patients Reporting Adverse Events (AE)
Measure Description Any type of adverse events
Time Frame 48 weeks  

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 (TS), defined as patients treated with Aptivus

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 
Participants Analyzed 
[Units: Participants]
 42 
Number of Patients Reporting Adverse Events (AE) 
[Units: Participants]
 
Patients with any adverse events   6 
Patients with any serious adverse events   1 
Patients with AE leading to discontinuation   4 
Patients with hepatic adverse events   1 
Patients with dyslipidemia   2 

No statistical analysis provided for Number of Patients Reporting Adverse Events (AE)



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

Measure Type Secondary
Measure Title Virologic Response
Measure Description Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.
Time Frame 48 weeks  

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 (TS), defined as patients treated with Aptivus

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 
Participants Analyzed 
[Units: Participants]
 42 
Virologic Response 
[Units: Number of participants]
 
Virologic response - Yes   0 
Virologic response - No   4 
Virologic response - Missing   38 

No statistical analysis provided for Virologic Response



3.  Secondary:   Change in CD4+ Cell Count From Baseline at Week 48   [ Time Frame: 48 weeks ]

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline at Week 48
Measure Description No text entered.
Time Frame 48 weeks  

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 
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