Acquired Immunodeficiency Syndrome Clinical Trial
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
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.
Study Hypothesis:
It was expected that nevirapine would decrease methadone levels in this patient population.
Comparison(s):
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).
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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