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.

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. Identifier: NCT00976950
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : August 16, 2012
Last Update Posted : March 20, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections
Interventions: Drug: Tipranavir
Drug: ritonavir

  Participant Flow

  Baseline Characteristics

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

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

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