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The Effects of Illnesses on HIV Levels in the Body

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Qué se está recopilando

Recolección de datos

Quiénes están siendo reclutados

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 describe the magnitude and duration of changes in HIV-1 RNA levels during and after an acute febrile illness. To identify factors associated with increases, i.e., type of illness ultimately diagnosed (bacterial, viral, fungal), CD4 cell count, and antiretroviral treatment regimen. To describe changes in phenotypic markers of immune activation/dysregulation of CD4 and CD8 lymphocyte subsets and their relationship to intercurrent illness. To describe changes in plasma cytokines and soluble activation markers and their relationship to plasma HIV-1 viremia during and after the onset of intercurrent illness. To characterize the viral biologic phenotype and the viral drug susceptibility genotype before, during, and after the onset of an acute febrile illness. To characterize the expression of HIV-1 co-receptors before, during, and after the onset of an acute febrile illness Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection. The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load, viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation, plasma cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms. Repeated episodes of intercurrent infections have been postulated to be an important stimulus for progression of HIV infection. The study of intercurrent illness in patients with initially undetectable viral load removes viral load as a possible cause for virologic and immunologic changes and allows for a more direct association of the intercurrent illness with changes in viral load, viral HIV-1 phenotypes, viral HIV-1 genotypes, and T cell phenotypes. Studying intercurrent illness and viral load provides an opportunity to characterize the potentially dynamic changes not only in viral load but also in phenotypic markers of T cell activation, plasma cytokine levels, phenotypic and genotypic changes in circulating virus, and HIV-1 tropisms. This is a study to determine whether patients exhibit a temporary burst of viral replication or other changes in response to intercurrent febrile illness. Although there is no study treatment, patients on this study must be co-enrolled in at least 1 other ACTG antiretroviral treatment study. Plasma HIV-1 RNA and other variables are measured at the time of presentation, on Day 3, and at Weeks 1, 2, 4, 8, 16, and 24.

Título OficialThe Impact of Intercurrent Illness on HIV Viral Load 
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 26 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.

Cómo se recopila la información
Algunos estudios utilizan enfoques alternativos o combinados que no encajan estrictamente en los modelos prospectivos, retrospectivos o transversales. Estos pueden incluir cronogramas híbridos, simulaciones o métodos observacionales adaptativos.Otras formas de recopilar datos
Prospectivo
: Estos estudios recopilan nuevos datos a lo largo del tiempo del presente en adelante.

Retrospectivo
: Estos estudios utilizan historiales médicos u otros datos pasados.

Transversal
: Estos estudios recopilan datos en un momento específico.

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
HIV Infections
Criterios

Inclusion Criteria Patients must have: * HIV-1 infection documented by any licensed ELISA test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA or a second antibody test by a method other than ELISA at any time prior to study entry. * Undetectable plasma HIV-1 RNA (by Roche Amplicor Assay) within 8 weeks prior to study entry. * Documented temperature above 101degrees F during at least 1 of the 2 days prior to the day of screening and present on the day of screening, or documented temperature above 101 F on the day of the screening but no fever on 1 of the 2 days prior to screening. \[AS PER AMENDMENT 7/7/98: * Documented temperature above 101degrees F on the day of the screening.\] * Co-enrollment in at least 1 other ACTG antiretroviral treatment study (NOTE: * Co-enrollment is approved and encouraged with the following ACTG studies: * 343, 347, 359, 368, 370, and 372). \[AS PER AMENDMENT 7/7/98: Must be enrolled in either an ACTG antiretroviral therapy study or a pharmaceutical company-sponsored antiretroviral therapy study prior to entry. Co-enrolled in a non-ACTG pharmaceutical company-based study must have a baseline viral isolate accessible for use in this study.\] * Written informed consent of a parent or guardian if under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Interruption of current antiretroviral therapy due to the onset of acute intercurrent illness. Concurrent Medication: Excluded: * Patients receiving IL-2. Patients with the following prior conditions are excluded: * Change in antiretroviral therapy combination within 8 weeks prior to study entry. Required: * Concurrent enrollment in an ACTG antiretroviral therapy study \[or, AS PER AMENDMENT 7/7/98, in a non-ACTG pharmaceutical company-sponsored antiretroviral treatment study\]. * Stable antiretroviral and/or nucleoside analog therapy for 8 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 14 ubicaciones
Suspendido
Univ of Alabama at BirminghamBirmingham, United StatesVer ubicación
Suspendido
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendido
Univ of Colorado Health Sciences CtrDenver, United States
Suspendido
Howard UnivWashington, United States

Completado14 Centros de Estudio