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

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00447902
First received: March 14, 2007
Last updated: April 25, 2014
Last verified: April 2014
History of Changes
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy 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
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
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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.
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  
Number of Participants  
[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
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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 ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Time to Treatment Failure
Measure Description For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.
Time Frame After Day 1 of treatment until the end of the trial  
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.
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  
Number of Participants Analyzed  
[units: participants]
 		  0     0  
Time to Treatment Failure          

No statistical analysis provided for Time to Treatment Failure



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 ]
  Show Outcome Measure 12

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


  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 Call Center
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: NCT00447902     History of Changes
Other Study ID Numbers: 1182.99
EudraCT No.: 2005-005023-33
Study First Received: March 14, 2007
Results First Received: September 25, 2009
Last Updated: April 25, 2014
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología)
Brazil: Agência Nacional de Vigilância Sanitária - ANVISA
France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)
Germany:
Italy: Comitato Etico Locale per la Sperimentazione Clinica Osp. L. Sacco - Milano
Portugal: INFARMED - Instituto Nacional da Farmácia e do Medicamento Parque da Saúde de Lisboa Av. do Brasil Lisboa
Spain:
United States: Food and Drug Administration