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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00273988 |
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.
Condition | Intervention | Phase |
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Acquired Immunodeficiency Syndrome |
Drug: nevirapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics Study to Evaluate Interaction Between Nevirapine and Methadone in HIV-1 Infected Opioid-Dependent Adults |
Estimated Enrollment: | 10 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | October 2003 |
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).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients who met the following laboratory parameters:
Exclusion criteria:
Ireland | |
Department of Genito Urinary Medicine, St James' Hospital | |
Dublin, Ireland, 8 |
Study Chair: | Boehringer Ingelheim Study Coordinator | BIL UK / Ireland |
Study ID Numbers: | 1100.1390 |
Study First Received: | January 9, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00273988 History of Changes |
Health Authority: | Ireland: Irish Medicines Board |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Methadone Nevirapine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Pathologic Processes Anti-Retroviral Agents Syndrome Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Disease |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |