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.

Ages Eligible for Study:  up to 72 Months   (Child)
Sexes Eligible for Study:  All
Accepts Healthy Volunteers:  No
Sampling Method:  Probability Sample