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Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome (IRIS)

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Conditions

Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections

Study type

Observational

Funder types

Other

Identifiers

NCT01557803
MRU-HAS 006/2012

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years
  • Informed consent
  • ART naive

Exclusion criteria

  • No informed consent
  • History of ART use
  • Pregnancy

Trial design

107 participants in 1 patient group

Starting ART
Description:
Adult patients starting anti retroviral therapy for the first time

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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