We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Hide Participant Flow

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


  Outcome Measures
  Show All 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
  Hide 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
No text entered.


  More Information