Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

Completed

• Conditions: Immune Reconstitution Inflammatory Syndrome; Opportunistic Infections

• Registration Number: NCT01557803
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Primary Completion: 2014-02
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Age > 18 years
• Informed consent
• ART naive

Exclusion Criteria

• No informed consent
• History of ART use
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IRIS	12 months	Development of immune reconstitution inflammatory syndrome

Secondary Outcome Measures

Name	Time	Method
Time to IRIS	12 months	Time to development of immune reconstitution inflammatory syndrome

Trial Locations

Locations (1)

Medical Research Unit - Albert Schweitzer Hospital; 🇬🇦 Lambaréné, Moyen Ogoué, Gabon