A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection
Colección de datos
Complejo Relacionado con el SIDA+13
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Tratamiento
Resumen
In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone. Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 180 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: * Intravenous and/or intramuscular immunoglobulin. * Acyclovir (no more than 30 mg/kg/day PO). * Ketoconazole (no more than 10 mg/kg/day). * Nystatin. * Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours. * Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy. * Trimethoprim / sulfamethoxazole. * Amphotericin B (no more than 1 mg/kg for 5 days/week). * Aerosolized ribavirin for bronchiolitis. * Hematopoietic agents. * Other drugs with little nephro-, hepato-, or cytotoxicity. * Nutritional support for HIV wasting syndrome or malnutrition. Patients must have: * HIV infection. * Ongoing stable AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols. * Known allergy or sensitivity to ddC. * Cardiomyopathy. Concurrent Medication: Excluded: * Biologic modifiers other than IVIG, steroids, or hematopoietic agents. * Investigational medications unless approved by protocol chair. * Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given). Patients with the following prior conditions are excluded: * History of intolerance or toxicity to AZT. * History of symptomatic pancreatitis. * History of peripheral neuropathy or abnormal nerve conduction velocity test. Prior Medication: Excluded: * Antiretroviral agents other than AZT within 2 weeks of study entry. Required: * Ongoing stable AZT therapy for more than 6 weeks duration.
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 47 ubicaciones
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, United StatesAbrir Long Beach Memorial Med. Ctr., Miller Children's Hosp. en Google MapsUsc La Nichd Crs
Los Angeles, United StatesUCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, United StatesChildren's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United States