P1073: Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 Months of Age

This study was terminated April 23, 2015.

This was a multi-national study conducted in India, South Africa, and Tanzania under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health.

P1073 is a case controlled prospective, clinical, observational and pathogenesis study of HIV-infected infants and children (≥ 4 weeks to < 72 months of age) at international IMPAACT sites who are within 1 week of HAART initiation and if ≤ 12 months of age have had prior BCG immunization. The primary objectives of the study are to describe the incidence, severity and clinical features of IRIS events related to BCG (BCG-IRIS) and of unmasking and paradoxical IRIS events related to TB infection (TB-IRIS) among ART-naïve HIV-infected pediatric subjects, < 72 months of age, who are initiating HAART; to identify the nadir CD4 T-cell count and percentage and plasma viral load pre-HAART and two weeks post-HAART; and to determine if the occurrence of BCG-IRIS or TB-IRIS or OTHER-IRIS influences subsequent immunological and virological responses to HAART and disease progression.