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Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00530920
First received: September 17, 2007
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
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
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Reporting Groups
  Description
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily No text entered.
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily No text entered.
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily No text entered.

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  
Adverse Event                 0                 0                 3  
Withdrawal by Subject                 0                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily No text entered.
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily No text entered.
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily No text entered.
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     27     28     85  
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     26     24     78  



  Outcome Measures
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1.  Primary:   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) ]
  Show Outcome Measure 1

2.  Primary:   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) ]
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3.  Primary:   Trough Concentration (Cmin) of Tipranavir   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]
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4.  Primary:   Maximum Concentration (Cmax) of Tipranavir   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]
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5.  Primary:   Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))   [ Time Frame: Baseline (Day 0) to Final (Day 14) ]
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6.  Secondary:   Apparent Oral Clearance I(Cl/F) of Tipranavir   [ Time Frame: Final (Day 14) ]
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7.  Secondary:   Volume of Distribution (V/F) of Tipranavir   [ Time Frame: Final (Day 14) ]
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8.  Secondary:   Terminal Half-Life (t1/2) of Tipranavir   [ Time Frame: Final (Day 14) ]
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9.  Secondary:   Time to Cmax (Tmax) of Tipranavir   [ Time Frame: Final (Day 14) ]
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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) ]
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11.  Secondary:   Cp 24 h of Ritonavirfor QD and CP 12 h of Ritonavir for BID   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]
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12.  Secondary:   Apparent Oral Clearance I(Cl/F) of Ritonavir   [ Time Frame: Final (Day 13 for QD, Day 14 for BID) ]
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13.  Secondary:   Volume of Distribution (V/F) of Ritonavir   [ Time Frame: Final (Day 14) ]
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14.  Secondary:   Terminal Half-Life (t1/2) of Ritonavir   [ Time Frame: Final (Day 14) ]
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15.  Secondary:   Tmax of Ritonavir   [ Time Frame: Final (Day 14) ]
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16.  Secondary:   Cmax of Ritonavir   [ Time Frame: Visits baseline, 5, 7, 9 and 13 or 14 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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