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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: May 27, 2014
Last verified: May 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
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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) ]
  Hide Outcome Measure 12

Measure Type Secondary
Measure Title Apparent Oral Clearance I(Cl/F) of Ritonavir
Measure Description Ritonavir pharmacokinetics
Time Frame Final (Day 13 for QD, Day 14 for BID)  
Safety Issue No  

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

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
  30     25     24  
Apparent Oral Clearance I(Cl/F) of Ritonavir  
[units: L/h]
Geometric Mean ( Geometric Coefficient of Variation )
  39.6  
  ( 44.0% )  
  44.4  
  ( 47.0% )  
  57.4  
  ( 48.9% )  

No statistical analysis provided for Apparent Oral Clearance I(Cl/F) of Ritonavir



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
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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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