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

NCT02147405 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

\- Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms soon after starting HIV medications. Often these symptoms are caused by immune reconstitution inflammatory syndrome (IRIS). Researchers want to study why and how people develop IRIS and how best to prevent and treat it.

Objectives:

\- To learn the causes and effects of IRIS,and how to best manage it.

Eligibility:

\- Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those already taking HIV medicines with symptoms thought to be related to IRIS.

Design:

* Participants not on ART will have screening blood tests for CD4 count, HIV viral load and genetic testing.
* After the screening blood tests and before starting HIV medicines., participants will return for more than 1 visit for the following:
* review of medical history\<TAB\>
* physical and eye exams
* blood, urine, and tuberculosis (TB) tests
* electrocardiogram (EKG)
* chest x-ray
* apheresis: a blood drawing procedure where blood is removed from a vein, white blood cells are separated and collected, and the rest of the blood is returned to the person using another vein
* \- PET scan - a procedure where a small amount of radioactive material is injected in a vein. The participant then lies on a table that slides into a scanner which takes images of the body.
* lymph node biopsy
* stool collection by swab
* After completion of the above, HIV medicines will be started.
* Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12 weeks. Some of the tests above may be repeated.
* Participants already on HIV medicines who may have IRIS will be screened over a 4 week time period to see if they really are experiencing IRIS. The screening process will include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and then every 12 weeks.
* The study will last 1 year for both groups but may be extended to 2 years (3 additional appointments) for some participants.

Conditions

  • Immune Reconstitution Inflammatory Syndrome

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-30
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147405 on ClinicalTrials.gov