Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome.

Background:

Immune Reconstitution Inflammatory Syndrome (IRIS) is a term used to describe the paradoxical worsening of a pre-existing infection or the presentation of a previously undiagnosed condition in HIV infected patients soon after the commencement of antiretroviral therapy (ART).
Rationale: Prediction and diagnosis of IRIS remains complex and pathogenesis is incompletely understood.



Study design & setting:

Prospective, observational cohort with nested case-control design; 200 HIV infected patients starting ART will be followed in and around Lambaréné, Gabon.



Methods:

Patients will be followed up monthly; clinical and laboratory data will be collected and plasma will be stored for later analysis. Putative biomarkers will be assessed for their predictive value and insight will be obtained in which inflammatory pathways become activated during the different appearances of IRIS.

The purpose of this study is:

1. To identify clinical and biological predictors for the development of IRIS in HIV infected patients and;

2. To obtain insight into the pathogenesis of this syndrome;

3. To describe the epidemiological pattern of IRIS in Gabon.

Scheduled follow up visits:

1. 2 weekly the first 2 months;

2. Month 3-12 monthly.

Enrolment:

Extensive history & physical exam, routine chest X ray & abdominal ultrasound (signs of TB), routine haematology & chemistry & serology (hep B & TPHA), storage of plasma for later immunological assays, visual acuity, fundoscopy.



Folow up:

Extensive history & physical exam, abdominal ultrasound (monthly), routine haematology & chemistry, storage of plasma for later immunological assays, visual acuity, fundoscopy in case of detoriated visual acuity.