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.

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

Categories

Location
Topic

Clinical Trials

A5332: Randomized Trial to Prevent Vascular Events in HIV...

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months....

Read More

A5350: Effects of Visbiome Extra Strength on Gut Microbiome...

Many factors contribute to the development of aging-related conditions, including gastrointestinal (GI) diseases, such as...

Read More

A5349: Rifapentine-containing treatment shortening regimens...

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a...

Read More

A5354/EARLIER: Effect of Antiretroviral Treatment Initiated...

This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs...

Read More

A5345, Identification of Biomarkers to Predict Time to...

Brief Summary: The purpose of this study is to collect information about what happens when people pause, or temporarily stop...

Read More