Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir (BUTI)

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. Identifier: NCT00486330
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
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

  Participant Flow

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
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] 
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

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

Baseline Measures
   Tipranavir/Ritonavir (500mg/200mg) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (21 to 53) 
[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

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