Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02147405
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2014-05-22
Brief Title:
PET Imaging and Lymph Node Assessment of IRIS in People With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 IRISand 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 historyTAB
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
- 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 IRISand 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 historyTAB
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
Detailed 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 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 An ART naive arm will enroll 140 patients who are ART-naSqrRoot ve with CD4 T cell counts 100 cellsmm3 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 60 participants who are ART-treated and meet criteria suspicious for IRIS 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-PETCT at designated study visits
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 An ART naive arm will enroll 140 patients who are ART-naSqrRoot ve with CD4 T cell counts 100 cellsmm3 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 60 participants who are ART-treated and meet criteria suspicious for IRIS 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-PETCT at designated study visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-I-0124 | None | None | None |