RecruitingNot Applicable

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

United States300 participantsStarted 2014-05-30

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documentation of HIV-1 infection. Results from outside facilities will be accepted for enrollment.
✓. No recent (within the past two years) treatment with combination anti-retroviral therapy (ART). Patients with limited (no more than 2-3 weeks) recent use of potent combination ART may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol
✓. Documented CD4+ cell count less than or equal to 100 cells/mm(3) within the past 8 weeks.
✓. Residence within the wider Washington D.C. area (within a 100-mile radius from the NIH Bethesda campus) and plans to stay in the area for 48 weeks
✓. Men or women age greater than or equal to 18 years.
✓. Ability and willingness of subject (or legal guardian/representative) to understand study requirements and give informed consent.
✓. Willingness to allow storage of blood or tissue samples for future research
✓. Willingness at time of screening to undergo study procedures (phlebotomy, apheresis, optional FDG-PET/CT and lymph node biopsy\*)

Exclusion criteria

What they're measuring

Correlate LN inflammation (by FDG-PET)

Timeframe: After completion of enrollment of all participants.

Pathogenesis studies

Timeframe: After completion of enrollment of all participants.

FDG-PET scans

Timeframe: After completion of enrollment of all participants.

Trial details

NCT IDNCT02147405

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2028-04-30

Contact for this trial

Irini Sereti, M.D.

(301) 496-5533 isereti@niaid.nih.gov

View on ClinicalTrials.gov More Immune Reconstitution Inflammatory Syndrome trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documentation of HIV-1 infection. Results from outside facilities will be accepted for enrollment.
✓. No recent (within the past two years) treatment with combination anti-retroviral therapy (ART). Patients with limited (no more than 2-3 weeks) recent use of potent combination ART may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol
✓. Documented CD4+ cell count less than or equal to 100 cells/mm(3) within the past 8 weeks.
✓. Residence within the wider Washington D.C. area (within a 100-mile radius from the NIH Bethesda campus) and plans to stay in the area for 48 weeks
✓. Men or women age greater than or equal to 18 years.
✓. Ability and willingness of subject (or legal guardian/representative) to understand study requirements and give informed consent.
✓. Willingness to allow storage of blood or tissue samples for future research
✓. Willingness at time of screening to undergo study procedures (phlebotomy, apheresis, optional FDG-PET/CT and lymph node biopsy\*)