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Observational Study of IRIS in People with AIDS

This study is looking at Immune Reconstitution Inflammatory Syndrome (IRIS) in people with HIV. IRIS can happen when people with HIV start taking antiretroviral therapy (ART) and their immune system begins to recover, sometimes causing new or worsening symptoms. Researchers want to understand why IRIS happens, how it affects people, and the best ways to prevent and treat it. They will use PET scans to look at inflammation in lymph nodes and conduct other studies to learn more about the causes of IRIS. You might be able to join if you are an adult with HIV, aged 18 to 100, who is about to start ART with a low CD4 count, or if you are already on ART and have symptoms that might be IRIS.

Study design
This is an observational study with two groups, aiming to enroll 300 participants. It is not a randomized study.
What's involved
If you are not on ART, you will have screening blood tests before starting HIV medicines. The ART-naive group will be followed for 48 weeks, with an optional extension up to 96 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants in the ART-naive group will be followed for 48 weeks, with an optional extension up to 96 weeks.

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NCT02147405

PET Imaging and Lymph Node Assessment of IRIS in People With AIDS

Recruiting
Not specifiedAges 18+Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~300 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlate LN inflammation (by FDG-PET)
Measured over After completion of enrollment of all participants.
+2 more outcomes measured

Conditions

Immune Reconstitution Inflammatory Syndrome

Explore related trials

HIV InfectionImmune reconstitution inflammatory syndromeHIV Infection

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Irini Sereti, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Irini Sereti, M.D.
[email protected]
(301) 496-5533
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Potential participants who lack decision-making capacity to consent to research participation may enroll in this study at the discretion of the investigator if this incapacity is expected to last for a short period of time.
Potential participants who lack decision-making capacity to consent to research participation may enroll in this study at the discretion of the investigator if this incapacity is expected to last for a short period of time.

What this trial measures

  • Correlate LN inflammation (by FDG-PET)After completion of enrollment of all participants.

    Correlate LN inflammation (by FDG-PET) and degree of fibrosis as assessed by immunohistochemistry (IHC) with development of IRIS and degree if immune reconstitution after 1 year of ART

  • Pathogenesis studiesAfter completion of enrollment of all participants.

    Pathogenesis studies to evaluate role of myeloid cells in periphery and LN in IRIS

  • FDG-PET scansAfter completion of enrollment of all participants.

    FDG-PET measurements and correlations with viremia, biomarkers, OI, immune recovery of B cells and Tfh cells with ART