Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
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StatutTerminé
Les sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborateurs
University Hospital Tuebingen
Albert Schweitzer Hospital
ESSAI CLINIQUE: NCT01557803
BioSeek: NCT01557803
Mots clés
Abstrait
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.
Rendez-vous
Dernière vérification: | 12/31/2014 |
Première soumission: | 03/15/2012 |
Inscription estimée soumise: | 03/18/2012 |
Première publication: | 03/19/2012 |
Dernière mise à jour soumise: | 01/12/2015 |
Dernière mise à jour publiée: | 01/13/2015 |
Date de début réelle de l'étude: | 12/31/2011 |
Date d'achèvement primaire estimée: | 01/31/2014 |
Date estimée d'achèvement de l'étude: | 12/31/2014 |
Condition ou maladie
Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections
Phase
-
Groupes d'armes
Bras | Intervention / traitement |
---|---|
Starting ART Adult patients starting anti retroviral therapy for the first time |
Critère d'éligibilité
Âges éligibles aux études | 18 Years À 18 Years |
Sexes éligibles à l'étude | All |
Méthode d'échantillonnage | Non-Probability Sample |
Accepte les bénévoles en santé | Oui |
Critères | Inclusion Criteria: - Age > 18 years - Informed consent - ART naive Exclusion Criteria: - No informed consent - History of ART use - Pregnancy |
Résultat
Mesures des résultats primaires
1. IRIS [12 months]
Development of immune reconstitution inflammatory syndrome
Mesures des résultats secondaires
1. Time to IRIS [12 months]
Time to development of immune reconstitution inflammatory syndrome