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Trial record 58 of 186 for:    BUPRENORPHINE AND NALOXONE

Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir (BUTI)

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ClinicalTrials.gov Identifier: NCT00486330
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University

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
Enrollment 12
Recruitment Details 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 There were no pre-assignment exclusion criteria.
Arm/Group Title Tipranavir/Ritonavir (500mg/200mg)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12 [1]
Completed 10 [2]
Not Completed 2
Reason Not Completed
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.
Arm/Group Title Tipranavir/Ritonavir (500mg/200mg)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
44
(21 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tipranavir/Ritonavir (500mg/200mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Geometric Mean (Full Range)
Unit of Measure: h*ng/mL
43.7
(16.4 to 112.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tipranavir/Ritonavir (500mg/200mg)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Tipranavir/Ritonavir (500mg/200mg)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tipranavir/Ritonavir (500mg/200mg)
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tipranavir/Ritonavir (500mg/200mg)
Affected / at Risk (%) # Events
Total   2/12 (16.67%)    
Hepatobiliary disorders   
Elevated transaminases  [1]  1/12 (8.33%)  1
Nervous system disorders   
Perioral numbness and lightheadedness  [2]  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
one subject withdrew due to elevated hepatic transaminases (>5x ULN; DAIDS Grade 3) detected during routine screening on day 4 which was attributed to known hepatic effects of tipranavir (2005).
[2]
One subject withdrew due to perioral numbness and lightheadedness likely due to RTV after the first day of study drug administration (Ritonavir Package Insert 2007)
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.
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
Layout table for Results Point of Contact information
Name/Title: R. Douglas Bruce
Organization: Yale University AIDS Program
Phone: 2037374040
EMail: robert.bruce@yale.edu
Layout table for additonal information
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