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A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Zidovudine

Medicamento
Quiénes están siendo reclutados

HIV Infections

De 3 meses a 12 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 3 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children. Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1 of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more weeks.

Título OficialA Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 3 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 12 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Todos los involucrados en el estudio saben qué tratamiento se está administrando. Esto se utiliza cuando no es posible o necesario ocultar los detalles del tratamiento a los participantes o investigadores.

Otras formas de enmascarar la información
Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

Doble ciego
: Ni los participantes ni los investigadores saben qué tratamiento se está administrando.

Triple ciego
: Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando.

Cuádruple ciego
: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 3 meses a 12 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Concurrent Treatment: Allowed: * Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements). Exclusion Criteria Co-existing Condition: Children with the following conditions are excluded: * Asymptomatic with T-lymphocyte deficiency. * Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS. * Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. * Hemoglobinopathy including sickle cell anemia. * Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. Children with the following conditions are excluded: * Asymptomatic with T-lymphocyte deficiency. * Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS. * Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. * Hemoglobinopathy including sickle cell anemia. * Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. Prior Medication: Excluded: * Suramin. * Ribavirin. * HPA 23. * Phosphonoformate. * Ansamycin. * Interleukin 2. * Interferon. * Excluded within 30 days of study entry: * All cytolytic chemotherapeutic agents, immunomodulating agents including steroids and immunoglobulin preparations. * Antivirals (acyclovir, ganciclovir). Prior Treatment: Excluded within 4 weeks of study entry: * Lymphocyte transfusions for immune reconstitution. * Excluded within 3 months of study entry: * Bone marrow transplant. Child who is seropositive for HIV antibody or has HIV viremia and presents with one or more of following clinical criteria and at least one of the laboratory criteria may be considered an ARC patient for purpose of study: * Clinical criteria: * Persistent oral candidiasis despite appropriate therapy. * Wasting syndrome characterized by failure to thrive and malnutrition. * Recurrent or chronic unexplained diarrhea. * Lymphadenopathy (more than 1 cm) at 2 or more noncontiguous sites. * Hepatomegaly with or without splenomegaly. * Encephalopathy with loss of developmental milestones and cortical atrophy present on computed tomography (CT) examination. * Recurrent bacterial infections (bacteremia, pneumonia, septic arthritis, meningitis). * Cutaneous anergy as defined by lack of delayed cutaneous hypersensitivity to selected antigens. * Laboratory criteria: * Hypergammaglobulinemia (IgG or IgA) defined as immunoglobulin values exceeding the maximum age-adjusted level. * Decreased number of total T-lymphocytes (2 SD from mean). * Absolute depression in T-helper cells to less than 500/mm3. * Depressed (equal to or more than 2 SD from normal mean) in vitro mitogen response to at least one antigen. * One positive HIV culture within 3 months of study entry into the study or blood obtained and culture pending. * Life expectancy greater than 6 months. * Ambulatory and free of opportunistic infection at time of entry. * Reliably diagnosed disease at least moderately indicative of underlying cellular immunodeficiency and no known cause of underlying cellular immunodeficiency or other reduced resistance reported to be associated with that disease. * Disease accepted as sufficiently indicative of underlying cellular immunodeficiency by CDC. In absence of these opportunistic diseases, a histologically confirmed diagnosis of chronic lymphoid interstitial pneumonitis will be considered indicative of AIDS unless test(s) for HIV are negative.



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
Suspendido
Univ of Miami School of MedicineMiami, United StatesVer ubicación
Suspendido
Duke Univ Med CtrDurham, United States

Completado2 Centros de Estudio