Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier:
NCT00571961
First received: December 11, 2007
Last updated: October 19, 2012
Last verified: October 2012
Results First Received: May 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: HIV Infections
Interventions: Drug: Kaletra (lopinavir/ritonavir)
Drug: buprenorphine
Other: Clinical evaluations/Blood draws

  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
HIV negative subjects currently enrolled in a long-term buprenorphine maintenance therapy program for at least 3 months who have been on stable dose of buprenorphine/naloxone (BUP/NLX) for at least 3 weeks will be admitted to the General Clinical Research Center (GCRC) for pharmacokinetic (PK) blood draws at intervals over a 24-hour period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once admitted to the GCRC, subjects were maintained on 16 mg of BUP/NLX daily, except for 1 patient on 24 mg. As baseline, subjects on steady-state BUP/NLX were hospitalized and underwent pharmacokinetic investigation over a 24-hr period. Subjects served as their own controls.

Reporting Groups
  Description
Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.

Participant Flow:   Overall Study
    Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  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
Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.

Baseline Measures
    Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Median ( Full Range )
  42  
  ( 29 to 54 )  
Gender  
[units: participants]
 
Female     5  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)   [ Time Frame: 15 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
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  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, MD, MA, MSc
Organization: Yale University AIDS Program
phone: (203) 737-6133
e-mail: robert.bruce@yale.edu


Publications of Results:

Responsible Party: R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier: NCT00571961     History of Changes
Other Study ID Numbers: 0511000791, M118687
Study First Received: December 11, 2007
Results First Received: May 25, 2012
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board