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 National Institutes of Health (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 four 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 NIH in Bethesda, Maryland
- You have a primary care physician
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