Methadone Effects on Zidovudine (ZDV, AZT) Disposition
Methadone hydrochloride
+ Zidovudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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 first dose. On both days, all other doses are given orally. Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment, with further pharmacokinetic sampling. After hospitalization for 16 days total, patients continue AZT/methadone treatment on an outpatient basis, and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling. Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group, although they will not receive methadone treatment. Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location