Anakinra, A Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection

Stopped early · Phase 1

Conditions studied: HIV Infections, Neurologic Disorders

In brief

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.

Key facts

Study ID: NCT02527460
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 1
Starts: 2015-08-17
Expected to finish: 2018-03-02
Last updated by the study team: 2019-11-29

Who can join

Age: 18 and older, up to 61. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Presence of a neurologic condition that would confound study evaluations (eg, multiple sclerosis, Parkinson s disease). Neurologic conditions that would not interfere with study evaluations (eg, migraine, peripheral neuropathy) will be allowed.
Presence of a condition, other than HAND, associated with cognitive impairment (e.g. untreated severe sleep apnea) at screening
Presence of HIV-associated dementia as determined through participation in NIH protocol 13-N-0149 or the JHU Clinical Outcomes Core
Inability to provide informed consent
Past or current psychiatric illness that may interfere with protocol adherence (eg schizophrenia or bipolar disorder)
Use of any psychiatric medications unless stable greater than or equal to 3 months at the time of screening
Current asthma requiring treatment
History of any AIDS-defining opportunistic infection in the past two years or any history of a CNS opportunistic infection
History of lymphoma or melanoma
Any medical condition (eg, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis) that would make frequent study visits and travel difficult for the participant
Positive urine drug screen or active abuse of illegal drugs, narcotics or alcohol as determined by the study investigator at the time of screening or at baseline evaluations
Women who are pregnant or actively seeking to become pregnant
Women who are breastfeeding
Use of any systemic immunosuppressive medication, including TNF inhibitors, within five half lives of the drug prior to of screening
Contraindications to LP including: International Normalized Ratio (INR) >1.5, platelets <100,000/Microlitre, or inability to temporarily discontinue aspirin for 7-10 days and nonsteroidal anti-inflammatory drugs for 3 days prior to LP
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x laboratory upper limit of normal
Absolute neutrophil count <1000/mm\^3 or hemoglobin <10mg/dL
Estimated glomerular filtration rate <60 mL/min or a history of renal dialysis
Other laboratory abnormality that would make the study risky for the patient as determined by the study investigator
Acute or chronic hepatitis C virus infection determined by a detectable VL
Acute or chronic hepatitis B determined by detectable hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) IgM
History of tuberculosis (TB), or positive TB test at screening (QuantiFERON or tuberculin skin test)
Other infection (eg, influenza, urinary tract infection) that would affect response to anakinra, or that would represent a risk of significant infection based upon the known effects of anakinra, and the likely effects of anakinra on this population.
Receipt of live vaccine within four weeks of starting anakinra or planned within three months after study completion
Contraindication to MRI including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, some types of aneurysm clips (metal clips on the wall of a large artery), some types of metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, or shrapnel fragments. Participants who require sedation for claustrophobia during the MRI will not be excluded.

Where it is running

Johns Hopkins University — Baltimore, Maryland, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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