Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Interferon gamma-1b
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection. Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.
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 1 a 17 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: Required: AZT or ddI therapy. PCP prophylaxis. Allowed: Antipyretics. Antiemetics. Antihistamines. Decongestants. Skin creams and lotions. Immunizations according to current recommendations. Patients must have: Class P-2 symptomatic HIV infection. Ongoing AZT or ddI therapy of 6 months or longer duration. Exclusion Criteria Concurrent Medication: Excluded: Antiretroviral therapy other than AZT or ddI. Chemotherapy for active malignancy. Amphotericin B for systemic fungal infections. Patients with the following prior conditions are excluded: History of congestive heart failure or arrhythmias. History of congenital heart disease. History of seizure disorder requiring anticonvulsant medication. (NOTE: History of uncomplicated febrile seizures does not exclude.) Prior Medication: Excluded within 8 weeks prior to study entry: Immunomodulators other than IVIG. Prior Treatment: Excluded: Red blood cell transfusion within 4 weeks prior to study entry. Required: Ongoing AZT or ddI therapy of 6 weeks or longer duration. Ongoing PCP prophylaxis for more than 6 weeks duration. Ongoing alcohol or drug use.
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
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, United StatesAbrir The Children's Hosp. of Philadelphia IMPAACT CRS en Google MapsTexas Children's Hosp. CRS
Houston, United States