Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole and Dapsone and Their Hydroxylamine Metabolites
Clarithromycin
+ Rifabutin
+ Sulfamethoxazole-Trimethoprim
Infecciones Transmitidas por la Sangre+17
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed. In Part A, patients receive sulfamethoxazole-trimethoprim (SMX/TMP) alone for 2 weeks, then in combination with fluconazole, rifabutin, or both drugs, each over 2-week periods in a randomly assigned order. Patients in Part B receive the same regimens except with clarithromycin substituted for rifabutin. In Part C, patients receive dapsone alone for 2 weeks, then in combination with fluconazole, rifabutin, or both drugs in the same manner as in Part A. Part D patients receive the same regimen as those in Part C, except with clarithromycin substituted for rifabutin. Patients are followed every 2 weeks.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 48 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy provided patient has been on a stable dose for at least 4 weeks prior to study entry. Methadone for drug abuse programs provided patient has been on a stable dose for at least 4 weeks prior to the study. Patients must have: HIV infection. CD4 count >= 200 cells/mm3. No active opportunistic infection. Prior Medication: Allowed: Antiretroviral therapy. Methadone for drug abuse therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Suspicion of gastrointestinal malabsorption problems (at discretion of investigator). Known hypersensitivity to dapsone, SMX, or other sulfonamides, trimethoprim, clarithromycin, rifabutin or other rifamycins, fluconazole, or other azoles. G-6-PD deficiency or methemoglobinemia (in Part C and D patients only). Concurrent Medication: Excluded: Cytolytic agents. Amiodarone. Anesthetics, general. Astemizole. Azithromycin. Barbiturates. Carbamazepine. Cimetidine. Ciprofloxacin. Cisapride. Clarithromycin (except as required on study). Clotrimazole. Dexamethasone. Disulfiram. Erythromycin. Fluoroquinolones. Fluoxetine. Gestodene. Hydrochlorothiazide. Hypoglycemics, oral. Isoniazid. Itraconazole. Ketoconazole. Levomepromazine. Loratadine. MAO inhibitors. Methoxsalen. Miconazole. Nafcillin. Narcotic analgesics. Naringenin. Nifedipine. Norethindrone. Pentazocine. Phenothiazines. Phenytoin. Protease inhibitors. Quinidine. Ranitidine. Rifabutin (except as required on study). Rifampin. Sedative hypnotics. Sulfaphenazole. Terfenadine. Tranquilizers (unless allowed by investigator). Tricyclic and tetracyclic antidepressants. Troleandomycin. Warfarin. Concurrent Treatment: Excluded: Radiation therapy. Prior Medication: Excluded: Cytolytic agents within 5 years prior to study entry. Rifabutin and/or rifampin within 4 weeks prior to study entry. Fluconazoles or other azoles within 4 weeks prior to study entry. Glutathione, glutathione precursors, or related prodrugs within 2 weeks prior to study entry. Excluded within 72 hours prior to study entry: Amiodarone. Anesthetics, general. Astemizole. Azithromycin. Cimetidine. Ciprofloxacin. Cisapride. Clarithromycin. Dexamethasone. Disulfiram. Erythromycin. Fluoroquinolones. Fluoxetine. Hydrochlorothiazide. Hypoglycemics, oral. Isoniazid. Levomepromazine. Loratadine. MAO inhibitors. Methoxsalen. Nafcillin. Narcotic analgesics. Naringenin. Nifedipine. Norethindrone. Pentazocine. Phenothiazines. Phenytoin. Protease inhibitors. Quinidine. Ranitidine. Sedative hypnotics. Sulfaphenazole. Terfenadine. Tranquilizers (unless allowed by investigator). Troleandomycin. Warfarin. Excluded within 4 weeks prior to study entry: Barbiturates. Carbamazepine. Clotrimazole. Gestodene. Itraconazole. Ketoconazole. Miconazole. Omeprazole. Rifabutin. Rifampin. Tricyclic and tetracyclic antidepressants. Prior Treatment: Excluded: Blood transfusion within 1 week prior to study entry. Radiation therapy within 5 years prior to study entry. Active drug or alcohol abuse or dependence that would preclude completion of study.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
University of Washington AIDS CRS
Seattle, United States