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Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530920
First Posted: September 18, 2007
Last Update Posted: June 6, 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:
Boehringer Ingelheim
Results First Submitted: May 15, 2009  
Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
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
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily

Participant Flow:   Overall Study
    Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily   Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily   Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily
STARTED   30   27   28 
COMPLETED   30   25   24 
NOT COMPLETED   0   2   4 
Randomized but not treated                0                2                0 
Adverse Event                0                0                3 
Withdrawal by Subject                0                0                1 



  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.
Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment

Reporting Groups
  Description
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
Total Total of all reporting groups

Baseline Measures
   Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily   Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily   Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   25   28   83 
Age 
[Units: Years]
Mean (Standard Deviation)
 33  (7.54)   36.9  (8.04)   36.4  (8)   35.3  (7.94) 
Gender 
[Units: Participants]
       
Female   2   1   4   7 
Male   28   24   24   76 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))   [ Time Frame: Baseline (Day 0) to Final (Day 14) ]

2.  Secondary:   Apparent Oral Clearance I(Cl/F) of Tipranavir   [ Time Frame: Final (Day 14) ]

3.  Secondary:   Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

4.  Secondary:   Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

5.  Secondary:   Trough Concentration (Cmin) of Tipranavir   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

6.  Secondary:   Maximum Concentration (Cmax) of Tipranavir   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

7.  Secondary:   Volume of Distribution (V/F) of Tipranavir   [ Time Frame: Final (Day 14) ]

8.  Secondary:   Terminal Half-Life (t1/2) of Tipranavir   [ Time Frame: Final (Day 14) ]

9.  Secondary:   Time to Cmax (Tmax) of Tipranavir   [ Time Frame: Final (Day 14) ]

10.  Secondary:   AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

11.  Secondary:   Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

12.  Secondary:   Apparent Oral Clearance I(Cl/F) of Ritonavir   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]

13.  Secondary:   Volume of Distribution (V/F) of Ritonavir   [ Time Frame: Final (Day 14) ]

14.  Secondary:   Terminal Half-Life (t1/2) of Ritonavir   [ Time Frame: Final (Day 14) ]

15.  Secondary:   Tmax of Ritonavir   [ Time Frame: Final (Day 14) ]

16.  Secondary:   Cmax of Ritonavir   [ Time Frame: Visits baseline, 5, 7, 9 and 13 or 14 ]

17.  Secondary:   Clinical Abnormal Findings in Laboratory and Physical Examination   [ Time Frame: Screening through the end of the study (14 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00530920     History of Changes
Other Study ID Numbers: 1182.107
First Submitted: September 17, 2007
First Posted: September 18, 2007
Results First Submitted: May 15, 2009
Results First Posted: July 8, 2009
Last Update Posted: June 6, 2014