Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00530920
First received: September 17, 2007
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: May 15, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   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  
Number of Participants  
[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
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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
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Time Frame 14 days
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    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, other (not including serious) adverse events        
# participants affected / at risk     18/30     12/25     18/28  
Gastrointestinal disorders        
Abdominal pain upper † 1      
# participants affected / at risk     3/30 (10.00%)     1/25 (4.00%)     1/28 (3.57%)  
Diarrhoea † 1      
# participants affected / at risk     10/30 (33.33%)     3/25 (12.00%)     11/28 (39.29%)  
Flatulence † 1      
# participants affected / at risk     0/30 (0.00%)     2/25 (8.00%)     0/28 (0.00%)  
Nausea † 1      
# participants affected / at risk     3/30 (10.00%)     1/25 (4.00%)     4/28 (14.29%)  
General disorders        
Fatigue † 1      
# participants affected / at risk     1/30 (3.33%)     3/25 (12.00%)     2/28 (7.14%)  
Nervous system disorders        
Dizziness † 1      
# participants affected / at risk     2/30 (6.67%)     1/25 (4.00%)     2/28 (7.14%)  
Dysgeusia † 1      
# participants affected / at risk     2/30 (6.67%)     0/25 (0.00%)     0/28 (0.00%)  
Headache † 1      
# participants affected / at risk     2/30 (6.67%)     2/25 (8.00%)     4/28 (14.29%)  
Psychiatric disorders        
Insomnia † 1      
# participants affected / at risk     2/30 (6.67%)     0/25 (0.00%)     0/28 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.1



  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.


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.  


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


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00530920     History of Changes
Other Study ID Numbers: 1182.107
Study First Received: September 17, 2007
Results First Received: May 15, 2009
Last Updated: February 13, 2014
Health Authority: Italy: Comitato Etico Per La Sperimentazione Clinica Dei Medicinali Az. San. - Firenze