Completado

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

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

Ganciclovir

Medicamento
Quiénes están siendo reclutados

Cytomegalovirus Retinitis

+ HIV Infections
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: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients. A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter. A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter. Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles (16 weeks). If CMV retinitis fails to arrest after initial induction, IV ganciclovir is administered for an additional 2 weeks.

Título OficialA Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 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 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.

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
Cytomegalovirus Retinitis
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Erythropoietin, G-CSF, or GM-CSF. * Antiretrovirals. Patients must have: * HIV infection. * Evaluable CMV retinitis with photographable lesions. * Life expectancy of at least 6 months. * No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression. * Corneal, lens, or vitreous opacification precluding funduscopic exam. * Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion. * Inability to obtain temporary IV access. * Requirement for permanent catheters for IV ganciclovir administration. * Uncontrolled diarrhea or nausea preventing ingestion of medicine. * Known hypersensitivity to IV or oral ganciclovir. Concurrent Medication: Excluded: * Immunomodulators. * Biologic response modifiers. * Interferon. * Related investigational agents. * CMV prophylaxis. * Systemic acyclovir. * Any nephrotoxic agent. * Any concomitant therapy that would prohibit use of ganciclovir. Prior Medication: Excluded: * Prior treatment for CMV retinitis. * More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.



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 6 ubicaciones
Suspendido
UCLA CARE Center CRSLos Angeles, United StatesVer ubicación
Suspendido
Rush Univ. Med. Ctr. ACTG CRSChicago, United States
Suspendido
Johns Hopkins Adult AIDS CRSBaltimore, United States
Suspendido
Cornell University A2201New York, United States

Completado6 Centros de Estudio