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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.

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ClinicalTrials.gov Identifier: NCT00976950
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : August 16, 2012
Last Update Posted : March 20, 2014
Sponsor:
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
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aptivus and Ritonavir
Hide Arm/Group Description TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Period Title: Overall Study
Started 42
Completed 36
Not Completed 6
Reason Not Completed
Adverse Event             3
Events with no relationship to Aptivus             3
Arm/Group Title Aptivus and Ritonavir
Hide Arm/Group Description TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
25.5  (10.4)
[1]
Measure Description: Age is available for 41 patients.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
19
  45.2%
Male
23
  54.8%
Baseline HIV RNA values  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
<= 50 cells/mm^3 2
51 - <251 cells/mm^3 19
251 - <451 cells/mm^3 13
>= 451 cells/mm^3 8
1.Primary Outcome
Title Number of Patients Reporting Adverse Events (AE)
Hide Description Any type of adverse events
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS), defined as patients treated with Aptivus
Arm/Group Title Aptivus and Ritonavir
Hide Arm/Group Description:
TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: 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
2.Secondary Outcome
Title Virologic Response
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS), defined as patients treated with Aptivus
Arm/Group Title Aptivus and Ritonavir
Hide Arm/Group Description:
TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Number of participants
Virologic response - Yes 0
Virologic response - No 4
Virologic response - Missing 38
3.Secondary Outcome
Title Change in CD4+ Cell Count From Baseline at Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set with with non-missing data at the visit
Arm/Group Title Aptivus and Ritonavir
Hide Arm/Group Description:
TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
85.8  (29.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aptivus and Ritonavir
Hide Arm/Group Description ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
All-Cause Mortality
Aptivus and Ritonavir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aptivus and Ritonavir
Affected / at Risk (%)
Total   1/42 (2.38%) 
Infections and infestations   
Pulmonary tuberculosis  1  1/42 (2.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aptivus and Ritonavir
Affected / at Risk (%)
Total   0/42 (0.00%) 
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00976950     History of Changes
Other Study ID Numbers: 1182.147
First Submitted: September 14, 2009
First Posted: September 15, 2009
Results First Submitted: May 30, 2012
Results First Posted: August 16, 2012
Last Update Posted: March 20, 2014