A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Colección de datos
Complejo Relacionado con el SIDA+13
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Tratamiento
Resumen
Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI. Patients are divided into two cohorts. Subjects will be stratified by age 3 months to < 24 months and >= 24 months to 12 years. Fifty % of patients from each age group will be assigned to each cohort. Cohort 1 receives ddI monotherapy for 4 weeks, followed by combination ddl/ribavirin therapy for an additional 20 weeks. Cohort 2 receives combination ddI/ribavirin for 24 weeks. In both cohorts, after study medications are stopped, patients are treated with prescription antiretrovirals for 4 more weeks. \[AS PER AMENDMENT 7/2/96: Note: In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry.\]
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 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 3 meses a 12 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: Recommended: * PCP prophylaxis. Allowed: * Acetaminophen for no more than 72 hours. * Immunoglobulin. * Corticosteroids. * Erythropoietin. * G-CSF and GM-CSF. * Ethionamide or isoniazid for TB if no alternative available. * Immunizations according to current recommendations. Patients must have: * HIV infection. * Immunologic abnormality or clinical symptoms as detailed in the Disease Status field. * No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea. * Consent of parent or guardian. PER AMENDMENT 7/2/96: * At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration \>= 70 pg/ml at screening. Prior Medication: Allowed: * Up to 6 weeks of prior immunomodulator therapy. * Maternal immunomodulator or antiretroviral therapy, including during pregnancy. * Prior corticosteroids or intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Current grade 3 or worse neuropathy/lower motor neuropathy. * Clinical or laboratory grade 3 or worse toxicities. * Active serious bacterial infection. Concurrent Medication: Excluded: * Chemotherapy for active malignancy. * Antiretrovirals other than study drugs. * Immunomodulators unless specifically allowed. Patients with the following prior condition are excluded: * History of grade 3 or worse neuropathy/lower motor neuropathy. Prior Medication: Excluded: * Prior ddI or oral ribavirin. * Aerosolized ribavirin within 6 weeks prior to study entry. * Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry. Ongoing drug or alcohol abuse.
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 15 ubicaciones
Children's Hosp of Washington DC
Washington D.C., United StatesAbrir Children's Hosp of Washington DC en Google MapsHoward Univ Hosp
Washington D.C., United StatesUniv of Florida Health Science Ctr / Pediatrics
Jacksonville, United StatesTulane Univ / Charity Hosp of New Orleans
New Orleans, United States