Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.

After 6 days of inpatient detoxification with clonidine, patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose, followed by determination of plasma and urine pharmacokinetics. On the second day of AZT dosing, the alternate form of administration will be used for the fi...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Documented HIV infection.
• • CD4 count 100 - 500 cells/mm3.
• • No active opportunistic infection or wasting syndrome.
• • Opiate addiction or prior enrollment in a methadone treatment program (methadone recipients only).
• • Admission to General Clinical Research Center at Yale-New Haven Hospital for clonidine detoxification (methadone recipients only).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Inadequate IV access.
• • Benzodiazepine abuse.
• Concurrent Medication:
• Excluded:
• • Amiodarone.
• • Anesthetics, general.
• • Azithromycin.
• • Barbiturates.
• • Carbamazepine.
• • Cimetidine.
• • Ciprofloxacin.
• • Clarithromycin.
• • Dexamethasone.
• • Disulfiram.
• • Erythromycin.
• • Fluoroquinolones.
• • Fluoxetine.
• • Gestodene.
• • Hydrochlorothiazide.
• • Hypoglycemics, oral.
• • Isoniazid.
• • Itraconazole.
• • Ketoconazole.
• • Levomepromazine.
• • MAO inhibitors.
• • Methoxsalen.
• • Nafcillin.
• • Narcotic analgesics.
• • Naringenin.
• • Norethindrone.
• • Omeprazole.
• • Pentazocine.
• • Phenothiazines.
• • Phenytoin.
• • Quinidine.
• • Ranitidine.
• • Rifabutin.
• • Rifampin.
• • Sedative Hypnotics.
• • Sulfaphenazole.
• • Tranquilizers (except at discretion of investigator and protocol chair).
• • Tricyclic antidepressants.
• • Troleandomycin.
• • Warfarin.
• Prior Medication:
• Excluded within 4 weeks prior to study entry:
• • Rifampin or its derivatives.
• • Phenytoin.
• • Barbiturates.
• • Cimetidine.
• • Other drugs known to induce or inhibit hepatic microsomal enzymes.
• Excluded within 14 days prior to study entry:
• • Any other experimental drug.
• • Drugs with known nephrotoxic potential.
• Excluded within 72 hours prior to study entry:
• • Amiodarone.
• • Anesthetics, general.
• • Azithromycin.
• • Carbamazepine.
• • Ciprofloxacin.
• • Clarithromycin.
• • Dexamethasone.
• • Disulfiram.
• • Erythromycin.
• • Fluoroquinolones.
• • Fluoxetine.
• • Gestodene.
• • Hydrochlorothiazide.
• • Hypoglycemics, oral.
• • Isoniazid.
• • Itraconazole.
• • Ketoconazole.
• • Levomepromazine.
• • MAO inhibitors.
• • Methoxsalen.
• • Nafcillin.
• • Narcotic analgesics.
• • Naringenin.
• • Norethindrone.
• • Omeprazole.
• • Pentazocine.
• • Phenothiazines.
• • Quinidine.
• • Ranitidine.
• • Rifabutin.
• • Sedative Hypnotics.
• • Sulfaphenazole.
• • Tranquilizers (except at discretion of investigator and protocol chair).
• • Tricyclic antidepressants.
• • Troleandomycin.
• • Warfarin.
• • Continued active drug or alcohol abuse or dependence that would decrease the probability of study completion.

Trial Officials