HIV Infections Clinical Trial
Official title:
Anakinra, a Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |