PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Description
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…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
* ELIGIBILITY CRITERIA: ART NAIVE ARM INCLUSION CRITERIA: 1. Documentation of HIV-1 infection. Results from outside facilities will be accepted for enrollment. 2. 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 3. Documented CD4+ cell count less than or equal to 100 cells/mm(3) within the past 8 weeks. 4. Residence wi…
Location
- National Institutes of Health Clinical CenterBethesda, Maryland