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We conducted a nested case-control study in a cohort of patients initiating antiretroviral therapy (ART) to identify risk factors and common manifestations of immune reconstitution inflammatory syndrome (IRIS) and to validate the Robertson criteria for IRIS prediction. HIV-infected patients at the Tuberculosis Research Centre clinics, Chennai and Madurai, India, initiating ART between July 2004 and June 2005 were prospectively studied. Of 97 patients (62% men, median age 32 years, median CD4 count 63 cells/μL) included, 34 developed IRIS. IRIS was more common in patients with a prior history of tuberculosis (74% versus 52%, P = 0.04), median time to development was 46 days and the sensitivity and specificity of the Robertson criteria to predict IRIS were 91% and 22%, respectively. In this population, IRIS was a common event, more so among patients with prior tuberculosis, and neither the rate of CD4 increase nor the Robertson criteria were useful in predicting its development.

Immune reconstitution inflammatory syndrome in HIV-infected patients with and without prior tuberculosis