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Intranasal Treatment of HIV-associated Neurocognitive Disorders

NCT03277222 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-06-11

No results posted yet for this study

Summary

This study aims to see whether intranasal insulin is an effective treatment for problems with memory, concentration, slowed thinking, or any other cognitive function in people living with HIV/AIDS. This group of signs and symptoms are called 'HIV-associated neurocognitive disorders' or HAND. HAND can affect people living with HIV/AIDS even when they receive potent anti-HIV treatments. Treatment of HAND by specific medication or other means is not yet available. Intranasal insulin treatment has virtually no side-effects, and has already been tested in people with Alzheimer's disease, where it showed beneficial effects on memory, mood and quality of life

Conditions

  • HIV Associated Neurocognitive Disorder (HAND)

Interventions

BIOLOGICAL

IN insulin

IN insulin twice daily taken after breakfast and again after dinner using the nasal delivery device.

BIOLOGICAL

Sterile Saline placebo

Sterile Saline placebo twice daily taken after breakfast and again after dinner using the nasal delivery device.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Alberta

    collaborator OTHER

  • Epidemiology Coordinating and Research Centre, Canada

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Christopher Power, MD, FRCPC · University of Alberta

  • Michael J Gill, MBChB FACP · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-04-21
Completion
2019-04-21

Countries

  • Canada

Study Locations

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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 NCT03277222 on ClinicalTrials.gov