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Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir (BUTI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486330
First Posted: June 14, 2007
Last Update Posted: November 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University
Results First Submitted: February 25, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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) 
Overall Participants Analyzed 
[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


  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
First Submitted: June 12, 2007
First Posted: June 14, 2007
Results First Submitted: February 25, 2010
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012