Pharmacokinetic Study of Interaction Between Nevirapine and Methadone in HIV-1 Infected, Opioid-dependent Adults
|First Received Date ICMJE||January 9, 2006|
|Last Updated Date||May 18, 2012|
|Start Date ICMJE||April 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Clearance of methadone at steady state in the presence and absence of nevirapine.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00273988 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Pharmacokinetics of methadone at steady state in the presence and absence of nevirapine|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Pharmacokinetic Study of Interaction Between Nevirapine and Methadone in HIV-1 Infected, Opioid-dependent Adults|
|Official Title ICMJE||Pharmacokinetics Study to Evaluate Interaction Between Nevirapine and Methadone in HIV-1 Infected Opioid-dependent Adults|
The purpose of this study was to determine the effects of nevirapine treatment on the pharmacokinetics of methadone in HIV-1 infected, opioid-dependent adults who had been on a stable methadone maintenance therapy for at least five days prior to study entry.
Ten HIV-1 infected, opioid-dependent adults on stable methadone treatment were to be enrolled in this study. This was an open-label, sequential treatment study, with methadone pharmacokinetics sampling before and after twenty-one (21) days of nevirapine administration.
All patients received the same regimen. Methadone was administered in the first treatment period, and combination treatment of methadone and nevirapine was given in the second treatment period. In the first period, patients received methadone at their current steady state dose. In the second period (study days 1-21), they also received nevirapine 200mg qd (study days 1 to 14) and 200mg bid (study days 15 to 21). Blood samples were taken at the start of the first treatment period and at the end of the second treatment period for analysis of methadone and nevirapine pharmacokinetics parameters.
It was expected that nevirapine would decrease methadone levels in this patient population.
The study compared methadone steady state exposure in the absence and presence of steady state nevirapine. A range of pharmacokinetics parameters were assessed including clearance of methadone (the primary endpoint variable), area under the concentration-time curve, maximum concentration, time to maximum concentration and minimum concentration (measured for both methadone and nevirapine).
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Acquired Immunodeficiency Syndrome|
|Intervention ICMJE||Drug: nevirapine|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
CD4+ cell count at least 100 cells/mm3 (later amended to at least 50 cells/mm3), within 28 days prior to study day 0.
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Ireland|
|NCT Number ICMJE||NCT00273988|
|Other Study ID Numbers ICMJE||1100.1390|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Boehringer Ingelheim Pharmaceuticals|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Boehringer Ingelheim Pharmaceuticals|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP