Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02527460
Status:
TERMINATED
Last Update Posted:
2019-11-29
First Post:
2015-08-18
Brief Title:
Anakinra A Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Anakinra a Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection
Status:
TERMINATED
Status Verified Date:
2018-03-02
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
HIV can sometimes cause HIV-associated neurocognitive disorder or HAND HAND is HIV-associated neurocognitive disorder It can affect memory thinking or concentration It can cause mood changes HAND may be caused by HIV hiding in the central nervous system then causing inflammation Researchers want to see if a drug for inflammation Anakinra can help people with HIV
Objective
To see if a drug for inflammatory diseases is safe for people with HIV-infection on antiretroviral therapy
Eligibility
Adults 18-61 years old with HIV who are enrolled in another study
Design
Participants will be screened with medical history physical exam and blood and urine tests
Participants will have up to 15 study visits over 16 weeks
At study visit 1 participants will have
Screening tests repeated
Brain magnetic resonance imaging MRI scans They will lie on a table that slides into a metal cylinder in a strong magnetic field They will get a dye inserted by a thin plastic tube in a vein
Lumbar puncture The lower back will be numbed A needle will collect fluid from between bones in the back
Tests of memory thinking and attention Participants may also fill out forms and do tasks
Participants will learn how to inject the study drug Over 8 weeks they will give themselves the study drug at home every day They will do up to 3 injections at once They will write down their injections and any side effects
Participants will have 5 weekly visits while taking the study drug They will answer questions and have blood drawn
At weeks 8 and 16 they will have a visit that repeats visit 1
HIV can sometimes cause HIV-associated neurocognitive disorder or HAND HAND is HIV-associated neurocognitive disorder It can affect memory thinking or concentration It can cause mood changes HAND may be caused by HIV hiding in the central nervous system then causing inflammation Researchers want to see if a drug for inflammation Anakinra can help people with HIV
Objective
To see if a drug for inflammatory diseases is safe for people with HIV-infection on antiretroviral therapy
Eligibility
Adults 18-61 years old with HIV who are enrolled in another study
Design
Participants will be screened with medical history physical exam and blood and urine tests
Participants will have up to 15 study visits over 16 weeks
At study visit 1 participants will have
Screening tests repeated
Brain magnetic resonance imaging MRI scans They will lie on a table that slides into a metal cylinder in a strong magnetic field They will get a dye inserted by a thin plastic tube in a vein
Lumbar puncture The lower back will be numbed A needle will collect fluid from between bones in the back
Tests of memory thinking and attention Participants may also fill out forms and do tasks
Participants will learn how to inject the study drug Over 8 weeks they will give themselves the study drug at home every day They will do up to 3 injections at once They will write down their injections and any side effects
Participants will have 5 weekly visits while taking the study drug They will answer questions and have blood drawn
At weeks 8 and 16 they will have a visit that repeats visit 1
Detailed Description:
Objective HIV persists as a reservoir in the brain in several different cell types including macrophages microglia and astrocytes and this reservoir persists even when antiretroviral therapy ART suppresses the virus in blood This viral persistence in the CNS is thought to cause neuroinflammation through the release of inflammatory cytokines and chemokines HIV-infected patients who have evidence of neuroinflammation in CSF are more likely to have cognitive impairment even when the virus is optimally treated with ART This cognitive impairment currently named HIV-associated neurocognitive disorder HAND affects 20-37 of the HIV-infected and ART-treated population Without ART the rates of severe HAND are incredibly high but in the current era in areas where ART is widely available the cognitive deficits are often subtle Despite this reduction in the degree of impairment and fewer cases of overt dementia patients with HAND have poor medication adherence problems with decision making vocational disability and an overall reduced quality of life compared to HIV-infected patients without cognitive impairment
This phase 1 study of anakinra will investigate the safety of anakinra in patients with HIV on antiretroviral therapy Anakinra an IL-1 receptor antagonist that has broad anti-inflammatory effects has demonstrated safety and efficacy in two other inflammatory diseases rheumatoid arthritis and neonatal onset multisystem inflammatory disorder for which it is FDA-approved It has not yet been used in patients with HIV infection
Study Population The study will be conducted simultaneously at two centers the NIH Clinical Center and the Johns Hopkins University JHU Department of Neurology and will enroll twelve participants with HIV infection on antiretroviral therapy Approximately half of the patients will be enrolled at each site The study will not enroll patients with evidence of dementia
Design This is a single-arm open-label study of anakinra Participants will self-administer daily injections of anakinra for 8 weeks The dose will be increased over the first four weeks to minimize injection site reactions Participants will be evaluated prior to the first dose of anakinra weekly during the first five weeks at the end of anakinra administration and after an 8-week follow-up period without anakinra
Patients enrolled at the NIH will complete all visits there Patients enrolled at JHU will complete all visits there with the exception of the three study MRI s which will be completed at the NIH
Outcome Measures Safety will be assessed throughout the 8 weeks of treatment and during the 8-week followup period The anti-inflammatory effects of anakinra will be explored through analyses of cerebrospinal fluid and magnetic resonance imaging results before and after treatment
This phase 1 study of anakinra will investigate the safety of anakinra in patients with HIV on antiretroviral therapy Anakinra an IL-1 receptor antagonist that has broad anti-inflammatory effects has demonstrated safety and efficacy in two other inflammatory diseases rheumatoid arthritis and neonatal onset multisystem inflammatory disorder for which it is FDA-approved It has not yet been used in patients with HIV infection
Study Population The study will be conducted simultaneously at two centers the NIH Clinical Center and the Johns Hopkins University JHU Department of Neurology and will enroll twelve participants with HIV infection on antiretroviral therapy Approximately half of the patients will be enrolled at each site The study will not enroll patients with evidence of dementia
Design This is a single-arm open-label study of anakinra Participants will self-administer daily injections of anakinra for 8 weeks The dose will be increased over the first four weeks to minimize injection site reactions Participants will be evaluated prior to the first dose of anakinra weekly during the first five weeks at the end of anakinra administration and after an 8-week follow-up period without anakinra
Patients enrolled at the NIH will complete all visits there Patients enrolled at JHU will complete all visits there with the exception of the three study MRI s which will be completed at the NIH
Outcome Measures Safety will be assessed throughout the 8 weeks of treatment and during the 8-week followup period The anti-inflammatory effects of anakinra will be explored through analyses of cerebrospinal fluid and magnetic resonance imaging results before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 15-N-0183 | None | None | None |