Actively Recruiting
PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-01
300
Participants Needed
1
Research Sites
726 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older
- Documented HIV-1 infection
- For ART naive group: no recent combination ART treatment within 2 years except limited use of 2-3 weeks
- For ART naive group: CD4+ cell count less than or equal to 100 cells/mm3 within past 8 weeks
- For IRIS group: meet at least 4 of 5 criteria suspicious for IRIS including ART initiation/change, CD4 increase or viral load decrease, infectious/inflammatory symptoms, and attribution to a pathogen or condition
- Residence within 100-mile radius of NIH Bethesda campus (exceptions case-by-case for IRIS group)
- Ability and willingness to understand and consent to study requirements
- Willingness to allow storage of blood or tissue samples for future research
- Willingness to undergo study procedures including phlebotomy, apheresis, optional FDG-PET/CT, and lymph node biopsy
- Willingness to have genetic testing
- Participants should have or agree to establish a primary care physician by 24 weeks on study
You will not qualify if you...
- Active drug or alcohol use or dependence interfering with study adherence
- Pregnancy
- Inadequate venous access for blood draws and apheresis
- Breastfeeding
- Life-threatening illness requiring immediate treatment like PML or lymphoma
- Irreversible inability to consent
- History of significant medical non-adherence interfering with participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
I
Irini Sereti, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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