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Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation

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ClinicalTrials.gov Identifier: NCT00447902
Recruitment Status : Terminated
First Posted : March 15, 2007
Results First Posted : December 23, 2009
Last Update Posted : May 14, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: tipranavir
Drug: ritonavir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
With FDA and EMEA agreement, the trial was prematurely discontinued before reaching the target number of patients to be entered due to poor recruitment. For this reason analyzing and reporting data as planned for primary and secondary endpoints have not been performed. No objectives were reached and no conclusion can be drawn from this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient has been randomised by mistake in Brasil and so he was not treated

Reporting Groups
  Description
Standard of Care Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Therapeutic Drug Monitoring Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules

Participant Flow:   Overall Study
    Standard of Care   Therapeutic Drug Monitoring
STARTED   5   6 
COMPLETED   1   0 
NOT COMPLETED   4   6 
Adverse Event                0                3 
Protocol Violation                1                0 
Withdrawal by Subject                0                1 
included patients who discontinued                1                1 
Lack of Efficacy                2                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Standard of Care Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Therapeutic Drug Monitoring Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
Total Total of all reporting groups

Baseline Measures
   Standard of Care   Therapeutic Drug Monitoring   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 4   6   10 
Age 
[Units: Years]
Mean (Standard Deviation) 		 46.00  (2.90)   45.20  (5.40)   45.50  (4.40) 
Gender [1] 
[Units: Participants]
 		     
Female   1   1   2 
Male   3   5   8 
[1] Included patients who discontinued due to early termination


  Outcome Measures

1.  Primary:   Treatment Response at Week 48   [ Time Frame: 48 weeks ]
  Show Outcome Measure 1

2.  Primary:   The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study.   [ Time Frame: From the start of the study through 48 weeks. ]
  Show Outcome Measure 2

3.  Secondary:   Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit   [ Time Frame: After 4 weeks of treatment until the end of the trial ]
  Show Outcome Measure 3

4.  Secondary:   Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48   [ Time Frame: 24 and 48 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit   [ Time Frame: After 4 weeks of treatment until the end of the trial ]
  Show Outcome Measure 5

6.  Secondary:   Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48   [ Time Frame: Baseline, 24 and 48 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change in Viral Load From Baseline at Each Visit   [ Time Frame: After 4 weeks of treatment until the end of the trial ]
  Show Outcome Measure 7

8.  Secondary:   Time to Treatment Failure   [ Time Frame: After Day 1 of treatment until the end of the trial ]
  Show Outcome Measure 8

9.  Secondary:   Time to New AIDS or AIDS Related Progression Event or Death   [ Time Frame: After Day 1 of treatment until the end of the trial ]
  Show Outcome Measure 9

10.  Secondary:   Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48   [ Time Frame: after 2 weeks of treatment till Week 48 ]
  Show Outcome Measure 10

11.  Secondary:   Change in Ratio of CD38+/CD8+ From Baseline to Week 48   [ Time Frame: after 2 weeks of treatment till Week 48 ]
  Show Outcome Measure 11

12.  Secondary:   Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.   [ Time Frame: after 2 weeks of treatment till Week 48 ]
  Hide Outcome Measure 12

Measure Type Secondary
Measure Title Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.
Measure Description Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy.
Time Frame after 2 weeks of treatment till Week 48  

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.
The trial has been stopped due to a poor enrollment

Reporting Groups
  Description
Standard of Care Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
Therapeutic Drug Monitoring Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules

Measured Values
   Standard of Care   Therapeutic Drug Monitoring 
Participants Analyzed 
[Units: Participants]
 		 0   0 
Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.       

No statistical analysis provided for Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.



13.  Secondary:   Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48   [ Time Frame: after 2 weeks of treatment till Week 48 ]
  Show Outcome Measure 13

14.  Secondary:   Patients Adherence With Study Medication Based on Pill Count   [ Time Frame: After 4 weeks of treatment until the end of the trial ]
  Show Outcome Measure 14

15.  Secondary:   Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured   [ Time Frame: After 2 weeks of treatment until the end of trial ]
  Show Outcome Measure 15

16.  Secondary:   Occurrence of Tipranavir (TPV) Trough Concentration >120 μM   [ Time Frame: After 2 weeks of treatment until the end of trial ]
  Show Outcome Measure 16

17.  Secondary:   Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 17

18.  Secondary:   Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements   [ Time Frame: Baseline through 48 weeks ]
  Show Outcome Measure 18


  Serious Adverse Events


  Other Adverse Events


  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
Due to an early termination of the trial no analysis has been performed for primary and secondary endpoints


  More Information