PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 <=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
Disqualifiers
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Pregnancy will be an exclusion criterion for study entry given the intense nature of the protocol regarding blood draws, apheresis, biopsies and FDG-PET/CT imaging.
Inadequate venous access for phlebotomy and apheresis procedures as assessed by the study team.
Women who are breastfeeding.
Trial population
random sample of participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: ARV naive
Group B: IRIS
Trial outcomes
Primary outcomes
1
Correlate LN inflammation (by FDG-PET)
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
Time frame
After completion of enrollment of all participants.2
Pathogenesis studies
Pathogenesis studies to evaluate role of myeloid cells in periphery and LN in IRIS
Time frame
After completion of enrollment of all participants.3
FDG-PET scans
FDG-PET measurements and correlations with viremia, biomarkers, OI, immune recovery of B cells and Tfh cells with ART
Time frame
After completion of enrollment of all participants.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov