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NCT02147405 · ClinicalTrials.gov registry record
PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
A clinical trial of Immune Reconstitution Inflammatory Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT02147405: Recruiting study of Immune Reconstitution Inflammatory Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02147405 is a study of Immune Reconstitution Inflammatory Syndrome that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02147405, a study of Immune Reconstitution Inflammatory Syndrome, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study 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 appointme
Primary Outcome
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
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-05-30 |
| Est. Completion | 2028-04-30 |
What NCT02147405 shows while recruiting
NCT02147405 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Immune Reconstitution Inflammatory Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT02147405 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02147405 about?
NCT02147405 is a clinical study titled "PET Imaging and Lymph Node Assessment of IRIS in People With AIDS". 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...
What is the current status of trial NCT02147405?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2014-05-30. Estimated completion is 2028-04-30.
What conditions does trial NCT02147405 study?
This clinical trial studies the following conditions: Immune Reconstitution Inflammatory Syndrome.
Who is sponsoring clinical trial NCT02147405?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02147405 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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