Skip to main content
OpenTrials
Completed

NCT Number: NCT01557803

Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Research Unit - Albert Schweitzer Hospital

Lambaréné, Moyen Ogoué, BP118, Gabon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Informed consent
  • ART naive

Exclusion criteria

  • No informed consent
  • History of ART use
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. IRIS

    Time frame: 12 months

    Development of immune reconstitution inflammatory syndrome

Secondary outcomes

  1. Time to IRIS

    Time frame: 12 months

    Time to development of immune reconstitution inflammatory syndrome

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Albert Schweitzer Hospital
  • University Hospital Tuebingen

Registry information

Official study title

Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon

Acronym: IRIS

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 20, 2012
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.