PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
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|ClinicalTrials.gov Identifier: NCT02147405|
Recruitment Status : Recruiting
First Posted : May 26, 2014
Last Update Posted : October 1, 2019
- 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.
- To learn the causes and effects of IRIS,and how to best manage it.
- 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.
- 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:
<TAB><TAB>- review of medical history<TAB>
<TAB><TAB>- physical and eye exams
<TAB><TAB>- blood, urine, and tuberculosis (TB) tests
<TAB><TAB>- electrocardiogram (EKG)
<TAB><TAB>- 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.
<TAB><TAB>- lymph node biopsy
<TAB><TAB>- 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.
|Condition or disease|
|Immune Reconstitution Inflammatory Syndrome|
Immune reconstitution inflammatory syndrome (IRIS) in HIV infection represents a paradoxical, frequently inflammatory, immune response after initiation of antiretroviral (ART) therapy. The immunopathogenesis of IRIS remains elusive partially due to a lack of tissue sampling and a lack of detailed screening, including imaging, for subclinical opportunistic infections in many studies. Most pathogenesis studies to date have been performed in peripheral blood with a few notable exceptions of cryptococcal IRIS studies in which cerebrospinal fluid (CSF) samples were obtained and evaluated.
This is a 2-arm natural history study intended to evaluate the incidence, predictors and pathogenic mechanisms of IRIS in HIV-1 infected adults (age >18 years). A ART Naive arm will enroll 100 patients who are ART-naive with CD4+ T cell counts <100 cells/mm(3). These participants will initiate ART according to the clinical standard of care. Any opportunistic infections (OIs) or AIDS-defining illnesses identified prior to, during screening or at any point during the study, will also be treated according to standard of care. The IRIS arm will enroll 20 participants who are ART-treated and meet criteria suspicious for IRIS (Appendix D), with any CD4+ T cell count. The ART Naive arm will be followed for 48 weeks, with an optional extension up to week 96. The IRIS arm will be followed for 48 weeks after enrollment if the IRIS event is confirmed, also with an optional extension up to week 96. In both arms, subjects must have adequate venous access and will undergo collection of whole blood by phlebotomy, leukapheresis, lymph node biopsy, and fluorodeoxyglucose-positron emission tomography (FDG-PET/CT) at designated study visits.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS|
|Study Start Date :||May 22, 2014|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Patients that have not started or have ever been on ARV therapy.
Patients that are on medication but are possibly experiencing an IRIS event.
- Correlate LN inflammation (by FDG-PET) [ Time Frame: 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 studies [ Time Frame: After completion of enrollment of all participants. ]Pathogenesis studies to evaluate role of myeloid cells in periphery and LN in IRIS
- FDG-PET scans [ Time Frame: After 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147405
|Contact: Yolanda Mejia||(240) email@example.com|
|Contact: Irini Sereti, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Irini Sereti, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|