Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273988
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2006-01-09
Brief Title:
Pharmacokinetic Study of Interaction Between Nevirapine and Methadone in HIV-1 Infected Opioid-dependent Adults
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Pharmacokinetic Study to Evaluate the Interaction Between Nevirapine Viramune and Methadone in HIV-1 Infected Opioid-dependent Adults on Stable Methadone Maintenance Therapy
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Hypothesis
It was expected that nevirapine would decrease methadone levels in this patient population
Comparisons
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
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
Study Hypothesis
It was expected that nevirapine would decrease methadone levels in this patient population
Comparisons
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None