P1073 (DAIDS ID 10655): 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 Status Study Restriction

Closed to Follow Up

Non-US

What is P1073?

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.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

31441

BJ Medical College CRS

Pune, Maharashtra

India

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Clinical Trials Specialist: Laura Phillips

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.