Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
Solo los usuarios registrados pueden traducir artículos
Iniciar sesión Registrarse
El enlace se guarda en el portapapeles.
EstadoTerminado
Patrocinadores
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Colaboradores
University Hospital Tuebingen
Albert Schweitzer Hospital
ENSAYO CLÍNICO: NCT01557803
BioSeek: NCT01557803
Palabras clave
Abstracto
The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.
fechas
Verificado por última vez: | 12/31/2014 |
Primero enviado: | 03/15/2012 |
Inscripción estimada enviada: | 03/18/2012 |
Publicado por primera vez: | 03/19/2012 |
Última actualización enviada: | 01/12/2015 |
Última actualización publicada: | 01/13/2015 |
Fecha de inicio real del estudio: | 12/31/2011 |
Fecha estimada de finalización primaria: | 01/31/2014 |
Fecha estimada de finalización del estudio: | 12/31/2014 |
Condición o enfermedad
Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections
Fase
-
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Starting ART Adult patients starting anti retroviral therapy for the first time |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Método de muestreo | Non-Probability Sample |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Age > 18 years - Informed consent - ART naive Exclusion Criteria: - No informed consent - History of ART use - Pregnancy |
Salir
Medidas de resultado primarias
1. IRIS [12 months]
Development of immune reconstitution inflammatory syndrome
Medidas de resultado secundarias
1. Time to IRIS [12 months]
Time to development of immune reconstitution inflammatory syndrome