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A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection

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Qué se está evaluando

Didanosine

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: 26 de agosto de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given orally and intravenously, in infants and children with AIDS. The study also measures bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a preliminary assessment of the effectiveness of ddI on HIV replication. AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults, the dosing period will be extended to 104 weeks. Original design: Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS). AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults, the dosing period will be extended to 104 weeks. Original design: Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS). AMENDED: Dosing will proceed for 104 weeks at each dose level. Original design: Five patients are treated at the initial dose level. Because ddI is not stable in the acid environment of the stomach, oral doses of ddI follow administration of an antacid. An alternative method of dosing is to mix the reconstituted ddI with an appropriate volume of Maalox TC or Mylanta II. In order to determine the MTD, successive groups of 5 patients enter the study at a higher dose level after 3 patients have experienced 3 weeks of dosing and significant toxicities have not developed. Patients are assigned to treatment groups in the order in which they are enrolled. Dosing proceeds for 16 weeks at each dose level. However, consideration is given to escalating patients entered at the lowest dose to the next dose level after 10 weeks of dosing. The dose escalation continues until toxicities requiring dose modifications are found in 2 of 5 in any group.

Título OficialA Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 26 de agosto de 2008
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 25 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 Medication: Allowed: * Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis if this drug is extended to children. * Acute therapy not exceeding 7 days with oral or intravenous acyclovir for herpes simplex infections. * Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections during course of study at discretion of investigator after discussion with the sponsor. * Symptomatic therapy with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy as deemed necessary by the principal investigator. Patients must have: * Diagnosis of AIDS as defined by CDC or meeting CDC P2 classification. * Patients must be free of opportunistic infection or other serious bacterial, fungal, or parasitic infection at time of entry into study. * Life expectancy \> 6 months. * Parent or guardian (and patient as applicable) able to give informed consent. * Available for follow-up for at least 6 months. * Allowed: Hemophilia. Exclusion Criteria Co-existing Condition: Children with the following are excluded: * Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP. * Intractable diarrhea. * No venous access. * History of seizures within previous 2 years or currently requiring anticonvulsants for control. * Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of \< 10 percent on echocardiogram. * Renal disease. * Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study. Concurrent Medication: Excluded: * Antiretroviral drugs. * Zidovudine (AZT). * AL 721. * Interferon. * Corticosteroids. * Immunomodulating drugs. * Other systemic investigation agent. * Ribavirin. * Rifampin, barbiturates, or any other potent inducer or inhibitor of drug-metabolizing enzymes. * Cytotoxic anticancer therapy. * H-2 blockers. * Intravenous ketoconazole. * Immunoglobulin preparations. Children with the following are excluded: * Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP. * Intractable diarrhea. * No venous access. * History of seizures within previous 2 years or currently requiring anticonvulsants for control. * Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of \< 10 percent on echocardiogram. * Renal disease. * Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study. * Renal disease. Prior Medication: Excluded: * Any prior therapy which in the opinion of the investigator would make the patient unsuitable for study. Excluded within 2 weeks of study entry: * Trimethoprim / sulfamethoxazole. Excluded within 1 month of study entry: * Study drug or other antiretroviral drug or systemic investigational agent. * Any agent known as a potent inducer or inhibitor of drug metabolizing enzymes. * H-2 blockers. * Ketoconazole. * Immunoglobulin preparations. Excluded within 3 months of study entry: * Ribavirin. Excluded: * Zidovudine (AZT) for \> 6 months. * Cytotoxic anticancer therapy. Prior Treatment: Excluded within 4 weeks of study entry: * Blood transfusion. * Lymphocyte transfusions for immune reconstitution. * Bone marrow transplant.



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 5 ubicaciones
Suspendido
Univ of Alabama at BirminghamBirmingham, United StatesVer ubicación
Suspendido
Univ of Miami School of MedicineMiami, United States
Suspendido
The Regional Medical Ctr, MemphisMemphis, United States
Suspendido
Baylor College of MedicineHouston, United States

Completado5 Centros de Estudio