Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir (BUTI)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier:
NCT00486330
First received: June 12, 2007
Last updated: October 19, 2012
Last verified: October 2012
Results First Received: February 25, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: HIV Infections
Intervention: Drug: Buprenorphine, Tipranavir and 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
Subjects were recruited from buprenorphine maintenance treatment in New Haven over a year period. Subjects were hospitalized at baseline to be stabilized on buprenorphine/naloxone (BUP/NLX) therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no pre-assignment exclusion criteria.

Reporting Groups
  Description
Tipranavir/Ritonavir (500mg/200mg) Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.

Participant Flow:   Overall Study
    Tipranavir/Ritonavir (500mg/200mg)  
STARTED     12 [1]
COMPLETED     10 [2]
NOT COMPLETED     2  
Adverse Event                 2  
[1] Twelve subjects met inclusion/exclusion criteria
[2] Of the 12 subjects treated, two developed adverse events leading to study drug discontinuation.



  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
Tipranavir/Ritonavir (500mg/200mg) No text entered.

Baseline Measures
    Tipranavir/Ritonavir (500mg/200mg)  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ( Full Range )
  44  
  ( 21 to 53 )  
Gender  
[units: participants]
 
Female     4  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)   [ Time Frame: 10 days ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)
Measure Description Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.
Time Frame 10 days  
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.
No text entered.

Reporting Groups
  Description
Tipranavir/Ritonavir (500mg/200mg) Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.

Measured Values
    Tipranavir/Ritonavir (500mg/200mg)  
Number of Participants Analyzed  
[units: participants]
  10  
Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)  
[units: h*ng/mL]
Geometric Mean ( Full Range )
  43.7  
  ( 16.4 to 112.7 )  

No statistical analysis provided for Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)




  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
First, the sample size was small. Second, this study utilized a within-subject design with patients acting as their own controls and thereby resulting in less intra-patient variability in the analysis of BUP/NLX.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: R. Douglas Bruce
Organization: Yale University AIDS Program
phone: 2037374040
e-mail: robert.bruce@yale.edu


Publications of Results:

Responsible Party: R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier: NCT00486330     History of Changes
Other Study ID Numbers: BUTI
Study First Received: June 12, 2007
Results First Received: February 25, 2010
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration