A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
Colección de datos
Complejo Relacionado con el SIDA+21
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Tratamiento
Resumen
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative. Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age < 24 months or age >= 24 months. Steady-state pharmacokinetics will be examined in a subsample of 20 patients.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 32 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 1 meses a 6 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: * Steroids and intravenous immune globulin (IVIG). Patients must have: * Documented HIV infection. * Need for PCP prophylaxis. * Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX). One of the following required conditions: * Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179. NOTE: * Co-enrollment in other ACTG pediatric studies is permitted. Consent of parent or guardian is required. Prior Medication: Allowed: * Prior pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Active PCP. * Pancreatitis defined as amylase elevation associated with an elevated lipase that is \> 2 x upper limit of normal. Prior Medication: Excluded: * TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
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 13 ubicaciones
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, United StatesChildren's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United StatesChildren's National Med. Ctr., ACTU
Washington D.C., United States