Anakinra, A Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection
Status:
Terminated
Trial end date:
2018-03-02
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)