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

Study Location:

India

Topic:

HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT01240486?term=P1073&rank=1

IRB#:

NA_00038500

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Completed

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.

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