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A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir

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Qué se está evaluando

Ganciclovir

Medicamento
Quiénes están siendo reclutados

Cytomegalovirus Retinitis

+ HIV Infections
De 13 a 60 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

To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety, tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect preliminary laboratory evidence for antiviral activity and effectiveness of three dose regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate antiviral activity to dosage and to serum ganciclovir levels. CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses. CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses. In group A, 36 HIV seropositive patients with CMV viruria receive a single dose of intravenous ganciclovir followed by one of three oral dose regimens for 28 days. Twelve individuals are treated at each dose level. In group B, 12 patients with AIDS and CMV retinitis receive oral ganciclovir therapy. These 12 patients must have received an induction course of intravenous ganciclovir for 4 weeks prior to study entry and must have stable CMV retinitis. Measurements for both groups include pharmacokinetics, safety, and tolerance (history, physical examination, hematology, and serum chemistry), and CMV blood and urine cultures. In addition, there are weekly ophthalmologic evaluations for individuals in the group B study.

Título OficialA Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir 
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 48 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 13 a 60 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: * Topical acyclovir. There are two groups of patients. Group A must have: * Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV. * A positive urine culture for cytomegalovirus (CMV) within 4 weeks of study entry. * Not received prior ganciclovir therapy. Group B must have: * A diagnosis of AIDS by CDC criteria. * CMV retinitis diagnosed on funduscopic evaluation by an ophthalmologist. * Completed 4 weeks of intravenous ganciclovir with an improvement or stabilization of retinitis. The course of therapy should include a minimum of 24 days total of intravenous ganciclovir. * Patients in both groups must understand the nature of the study, agree to the tests required in the protocol, and must understand and sign an informed consent form approved by the appropriate Institutional Review Board (IRB) and by Syntex. Required: Group B: * 4 weeks of intravenous ganciclovir which should include a minimum of 24 days total of intravenous ganciclovir. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes. * Active CMV retinitis in which there is progression. * Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day. * Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar. * Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia. Concurrent Medication: Excluded: * Any investigational drug. * Acyclovir not specifically allowed. * Any other nucleoside analog. * Zidovudine (AZT). * Probenecid. * Aspirin. Patients with the following are excluded: * Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes. * Active CMV retinitis in which there is progression. * CMV end organ disease. * Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day. * Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar. * Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia. Prior Medication: Excluded within 4 days of study entry: * Antimetabolite. * Interferon. * Other nucleoside analog including zidovudine (AZT). Excluded for Group A: * Ganciclovir or other anti-cytomegalovirus therapy.



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 California / San Diego Treatment CtrSan Diego, United StatesVer ubicación
Suspendido
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States
Suspendido
Davies Med CtrSan Francisco, United States
Suspendido
Mount Zion Med CtrSan Francisco, United States

Completado5 Centros de Estudio