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A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

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

Zidovudine

+ Didanosine
Medicamento
Quiénes están siendo reclutados

HIV Infections

De 3 meses a 17 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 2 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children. Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.

Título OficialA Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 2 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 819 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
Ni los participantes ni los investigadores saben quién está recibiendo qué tratamiento. Esta es la forma más rigurosa de reducir el sesgo, asegurando que las expectativas no influyan en los resultados.

Otras formas de enmascarar la información
Abierto
: Todos saben qué tratamiento se está administrando.

Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

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 17 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 Medication: Allowed: * Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for \> 72 hours. * Systemic ketoconazole and fluconazole for acute therapy. Recommended: * Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis. Patients must have the following: * HIV infection. * Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted. Prior Medication: Allowed: * Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Active malignancy. * Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. * History of uncontrolled seizure disorder. * Grade 3 or higher peripheral neuropathy. * Cardiomyopathy. Concurrent Medication: Excluded: * Chemotherapy for malignancy. * Oral acidifying agents. * Acetaminophen, ibuprofen, or aspirin on a continual basis for \> 72 hours. * Ketoconazole or fluconazole for prophylaxis. * Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for \> 4 weeks. Patients with the following are excluded: * Active malignancy. * Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. * History of uncontrolled seizure disorder. * Grade 3 or higher peripheral neuropathy. Prior Medication: Excluded: * Steroids. * Intravenous immunoglobulin. * Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for \> 6 weeks and within 7 days prior to study entry. Prior Treatment: Excluded: * Red blood cell transfusion within four weeks prior to study entry. Ongoing drug or alcohol 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 80 ubicaciones
Suspendido
Univ of Alabama at Birmingham Schl of Med / PediatricsBirmingham, United StatesVer ubicación
Suspendido
Kaiser Permanente / UCLA Med CtrDowney, United States
Suspendido
UCSD Med Ctr / Pediatrics / Clinical SciencesLa Jolla, United States
Suspendido
Long Beach Memorial (Pediatric)Long Beach, United States

Completado80 Centros de Estudio