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Trial record 100 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)

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ClinicalTrials.gov Identifier: NCT00571961
Recruitment Status : Completed
First Posted : December 12, 2007
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Collaborator:
Abbott
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
Interventions Drug: Kaletra (lopinavir/ritonavir)
Drug: buprenorphine
Other: Clinical evaluations/Blood draws
Enrollment 12
Recruitment Details 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 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.
Arm/Group Title Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
42
(29 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)
Hide Description Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: (ng/mL)*hr
46.2  (15.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Hide Arm/Group Description 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.
All-Cause Mortality
Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Affected / at Risk (%)
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%
Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg
Affected / at Risk (%)
Total   0/12 (0.00%) 
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, MD, MA, MSc
Organization: Yale University AIDS Program
Phone: (203) 737-6133
EMail: robert.bruce@yale.edu
Layout table for additonal information
Responsible Party: R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier: NCT00571961     History of Changes
Other Study ID Numbers: 0511000791
M118687
First Submitted: December 11, 2007
First Posted: December 12, 2007
Results First Submitted: May 25, 2012
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012