A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Methadone hydrochloride
+ Fluconazole
Infections transmises par le sang+17
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination. Patients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days. Study drugs are administered as close to 8 AM as possible. Patients must visit the Fort Greene clinic on study days 1, 2, 15, and 16; they may receive treatment at their home clinics on days 3 through 14.
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.24 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 Concurrent Medication: Allowed: Antiretroviral therapy. Intermittent acetaminophen, aspirin, and ibuprofen. Patients must have: CD4 count >= 250 cells/mm3 within 3 months prior to study entry. Received a stable dose of methadone for a minimum of 30 days prior to study entry. Negative urine toxicology screen (except for methadone or methadone metabolites) within 14 days prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Ability and willingness to comply with protocol requirements. NOTE: Patients will be recruited from the methadone maintenance treatment program currently administered by Addiction Research and Treatment Corporation. Enrollment of women is encouraged. NOTE: Patients who are currently enrolled in CPCRA treatment and prophylaxis trials are eligible for this study provided they have been permanently removed from study drug on the other protocol. Prior Medication: Required: Stable dose of methadone for a minimum of 30 days prior to study entry. Allowed: Prior antiretroviral therapy (dose should be stable for 14 days prior to study entry). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known sensitivity to azoles, methadone, and other opiate narcotics. Concurrent Medication: Excluded: Amiodarone. Anesthetics, general. Barbiturates. Carbamazepine. Cimetidine. Ciprofloxacin. 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. Tricyclic antidepressants. Troleandomycin. Warfarin. Prior Medication: Excluded within 30 days prior to study entry: Ketoconazole, fluconazole, or itraconazole. Experimental drugs. Alcohol or illicit drug abuse.
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
Addiction Research and Treatment Corp
Brooklyn, United StatesOuvrir Addiction Research and Treatment Corp dans Google Maps