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

NCT02527460 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-11-29

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Neurologic Disorders

Interventions

DRUG

Anakinra

Participants will self-administer daily subcutaneous injections of anakinra for 8 weeks. The dose will be increased over the first four weeks to minimize injection site reactions. The target dose after four weeks is 300mg daily.

Sponsors & Collaborators

Principal Investigators

  • Avindra Nath, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-17
Primary Completion
2018-03-02
Completion
2018-03-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527460 on ClinicalTrials.gov