Methadone Effects on Zidovudine (ZDV, AZT) Disposition
Methadone hydrochloride
+ Zidovudine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.15 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site