NIAID HIV and Emerging Infectious Diseases Program

IRIS Study

Study name

A Cohort Observational Study Evaluating the Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients with CD4 Count less than or equal to 100 Cells/micro L who are Initiating Antiretroviral Therapy

Study number

06-I-0086

Goal of Study

The NIH is conducting a research study to evaluate patients who are initiating antiretroviral therapy (ART) for HIV to see if they develop conditions that may be related to immune reconstitution syndrome (IRIS). The purpose is to study what factors may lead to IRIS, what the outcome is after IRIS, and how to better define IRIS.

Study Regimen

We will perform blood tests and monitor your treatment at study entry; then we will see you at 2 weeks, 4 weeks, 8 weeks and 12 weeks. After that, we will see you about every three months for the first year. We will see you about every four months after the first year, with the duration of the study being about 4 years in total. Volunteers will be compensated.

Eligibility Criteria

• You are age 18 or older with documented HIV infection
• You have had no previous ART, unless ART was taken for <3 months and that was >6 months in the past
• Your CD4 < 100
• You reside within 120-mile radius of the NIH in Bethesda, MD
• You have a primary care physician

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