Suspendido

A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.

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

Foscarnet sodium

+ Ganciclovir
Medicamento
Quiénes están siendo reclutados

Encephalopathy

+ HIV Infections
+ Radiculitis
A partir de 13 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 29 de octubre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the safety and CSF penetration of combined ganciclovir and foscarnet treatment for presumed cytomegalovirus encephalitis or radiculomyelopathy. This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize the antiviral regimen. Current evidence suggests that a combination of ganciclovir and foscarnet may be the most efficacious therapy and appears to be well tolerated. This study will provide key information regarding safety and CSF penetration of the drugs available for treatment of these lethal diseases. It will also provide preliminary information regarding virologic factors relevant to CMV CNS disease. The study will also provide further data about the natural history of CMV brain infection detected by a combination of symptom complex and PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the CSF for the disease. This study proposes to investigate the use of combined ganciclovir and foscarnet to maximize the antiviral regimen. Current evidence suggests that a combination of ganciclovir and foscarnet may be the most efficacious therapy and appears to be well tolerated. This study will provide key information regarding safety and CSF penetration of the drugs available for treatment of these lethal diseases. It will also provide preliminary information regarding virologic factors relevant to CMV CNS disease. The study will also provide further data about the natural history of CMV brain infection detected by a combination of symptom complex and PCR identification of CMV in CSF and the potential of semi-quantitative PCR evaluation of the CSF for the disease. Patients will be stratified by clinical syndrome as having either primarily A) encephalitis; or B) radiculomyelitis. If patient has combined encephalitis and radiculomyelitis, then the patient will be stratified as encephalitis. CMV therapy with ganciclovir and foscarnet will first be given at an induction level and then a maintenance level. For the first 4 weeks, patients will be given foscarnet plus ganciclovir. Then for the following 20 weeks, patients will be given foscarnet plus ganciclovir with ganciclovir at a lower dose. NOTE: A maximum of 10 patients that have proven to be intolerant to either foscarnet or ganciclovir may receive the alternate agent alone. NOTE: Ganciclovir experienced subjects will be given GCV at induction and maintenance doses if tolerated. NOTE: Induction doses will not be re-started in the face of clinical relapse on switching to maintenance therapy.

Título OficialA Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease. 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 29 de octubre 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
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 administran los tratamientos a los participantes
Los participantes se dividen en diferentes grupos, y cada uno recibe un tratamiento específico al mismo tiempo. Esto ayuda a los investigadores a comparar la eficacia de los distintos tratamientos entre sí.

Otras formas de asignar tratamientos
Asignación a un solo grupo
: Todos reciben el mismo tratamiento.

Asignación cruzada
: Los participantes cambian de tratamiento durante el estudio.

Asignación factorial
: Los participantes reciben diferentes combinaciones de tratamientos.

Asignación secuencial
: Los participantes reciben tratamientos uno tras otro en un orden específico, posiblemente según su respuesta individual.

Otra asignación
: La asignación de tratamientos no sigue un diseño estándar o predefinido.

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.
A partir de 13 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
Encephalopathy
HIV Infections
Radiculitis
Criterios

Inclusion Criteria Concurrent Medication: Allowed: Patients with treated, stable toxoplasmosis encephalitis with documented stable CT or MR scans may be enrolled if maintenance suppressive therapy is continued. Patients must have: * Documented HIV infection. * Encephalopathy or radiculomyelitis. * CSF positive for CMV by PCR. * Signed informed consent from a parent or legal guardian for patients \< 18 years. * CSF cytological analysis should be obtained at the time of enrollment or within 2 weeks prior to enrollment. NOTE: * Co-enrollment is encouraged where study procedures do not conflict. Protocols investigating antiviral regimens with potential activity against CMV or other human herpes viruses will be ineligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Active CNS infection or malignancy, other than due to CMV or HIV. * A positive CSF VDRL. * Any evidence of active disease such as a substantial increase in cryptococcal antigen titer or positive culture. However, patients may be enrolled with stable, treated cryptococcal meningitis. * A dermatomal or disseminated varicella-zoster infection within 30 days prior to enrollment. * An active, symptomatic systemic infection, other tan HIV or CMV, for which the patient is not receiving stable therapy for at least 30 days. * Any other advanced disease likely to cause death in \<6 months. * Known intolerance to both foscarnet and ganciclovir. * Inability to safely perform a lumbar puncture. Concurrent Medication: Excluded: * Patients on prophylactic antiviral therapy at the time of study enrollment will not be allowed to continue this medication during the study. In the event of the appearance of HSV or VZV infections after enrollment in the study that require systemic therapy, acyclovir or other appropriate medication may be instituted. * Patients may not receive ZDV therapy during the initial 4 weeks of the study. Concurrent ZDV therapy will be started during maintenance therapy if tolerated. Bone marrow sparing antiretroviral therapy may be used at the investigator's discretion. NOTE: * Concurrent medications should be kept to a minimum because of possible interference with the assessment of both safety and pharmacokinetics. But medications absolutely necessary for the subject's welfare may be administered at the discretion of the investigator.



Centros del Estudio

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Este estudio no tiene datos de ubicaciónNo hay información disponible sobre las ubicaciones de este estudio. 

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