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A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients

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

Recolección de datos

Quiénes están siendo reclutados

Cytomegalovirus Infections

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

Historia Natural

Observación de la progresión de una enfermedad en personas no tratadas para comprender su curso y resultados típicos.
Observacional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 24 de junio de 2005
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To define relationships between 1) HIV load and risk of CMV disease, 2) CMV load and the risk of developing CMV disease, and 3) CMV load and HIV load. To establish threshold CMV and HIV load values in peripheral blood fractions that are associated with development of CMV end-organ disease. To define the natural history of CMV diseases in the context of highly active antiretroviral therapy (HAART). Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated. These studies would also further the understanding of the natural history of CMV disease within the context of AIDS. Natural history studies conducted prior to the advent of highly active antiretroviral therapy (HAART; i.e., 3-drug regimens that include HIV reverse transcriptase and protease inhibitors) have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts. Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART. Establishment of threshold CMV and HIV load values associated with CMV disease would facilitate identification of HIV-infected individuals truly at risk for CMV disease in whom targeted prophylactic interventions to prevent CMV disease would be indicated. These studies would also further the understanding of the natural history of CMV disease within the context of AIDS. Natural history studies conducted prior to the advent of highly active antiretroviral therapy (HAART; i.e., 3-drug regimens that include HIV reverse transcriptase and protease inhibitors) have demonstrated that the risk for developing CMV disease increases with progression of HIV disease and with declining CD4 counts. Presently the need exists to define the natural history of CMV disease in patients with AIDS within the context of HAART. In this prospective observational study, HIV-infected patients who are CMV-seropositive with no clinical symptoms of CMV disease at entry are followed for three years or until the diagnosis of CMV end-organ disease or death, whichever comes first. Clinical evaluations are performed at baseline and every 8 weeks. Blood samples for virologic studies are taken every 16 weeks.

Título OficialHuman Immunodeficiency Virus (HIV) and Cytomegalovirus (CMV) Viral Burden and Development of CMV End-Organ Disease: A Prospective Study in HIV-Infected Individuals. 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 24 de junio de 2005
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 400 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Historia Natural
Estos estudios observan la progresión de una enfermedad sin tratamiento activo, ayudando a entender cómo se desarrolla, cambia y afecta la calidad de vida con el tiempo.

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 Infections
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Antivirals with anti-CMV activity (such as acyclovir, ganciclovir, valacyclovir, valganciclovir, foscarnet, etc.) for reasons other than treatment of CMV disease. * Antivirals for prophylaxis or treatment of other herpesvirus infections. Patients must have: * Documented HIV-1 infection. * Documented evidence of CD4 count \<= 50 cells/mm3 in the previous 24 months. * Presence of serum CMV IgG antibodies. * No history of CMV end-organ disease or evidence of active CMV disease prior to study entry. NOTE: A history of positive CMV urine or blood cultures is acceptable as long as it has been determined that the patient does not have CMV end-organ disease. * Signed, informed consent of parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Ocular media opacities that preclude adequate visualization of the fundi. Patients with the following prior conditions are excluded: * History of CMV end-organ disease. * Any pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis.



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 36 ubicaciones
Suspendido
Univ of Alabama at BirminghamBirmingham, United StatesVer ubicación
Suspendido
Univ of Southern California / LA County USC Med CtrLos Angeles, United States
Suspendido
Los Angeles County - USC Med CtrLos Angeles, United States
Suspendido
UCLA CARE CtrLos Angeles, United States

Completado36 Centros de Estudio