TerminatedPhase 2

Intranasal Treatment of HIV-associated Neurocognitive Disorders

Stopped: Unable to find further eligible participants

Canada4 participantsStarted 2018-11-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented HIV-1 infection * Maintained on stable ART for ≥6 months (defined as undetectable viral load) * HAND-MND or -ANI diagnosis with evidence of clinical onset or progression within the prior 2 years, based on established criteria * Currently followed at the Southern Alberta Clinic (SAC; Calgary, AB, Canada) Exclusion Criteria: * HAND with a) changed dose of any medication for HIV-1 infection with a corresponding increase in viral load (e.g., ART), or b) secondary therapies for HAND (e.g., memantine, amphetamines). * Advanced liver, renal or lung disease, cancer or diabetes requiring insulin * Secondary diagnosis of neurocognitive impairment or other major neuropsychiatric illness such as epilepsy, Alzheimer's or Parkinson's diseases, major depression (PHQ-9 score \>10), or schizophrenia * Central nervous system lesion (diagnosed by neuroimaging) that may impair cognition * Previous allergic reaction to insulin or any of the carrier components. * Education \< 9 years or inability to read and write English fluently * Uncontrolled HIV-1 or hepatitis C co-infection * Inability to perform NP or questionnaire measures, functional illiteracy * Past or current substance abuse that could interfere with the study assessments as determined by the PI * Marijuana use on the day of NP testing * Uncontrolled cardiovascular disease (hypertension, coronary or peripheral artery disease)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Global Neurocognitive Performance from Baseline

Timeframe: 18 weeks

Trial details

NCT IDNCT03277222

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-21

View on ClinicalTrials.gov More HIV Associated Neurocognitive Disorder (HAND) trials