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


  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 ]


  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