Status:
TERMINATED
Intranasal Treatment of HIV-associated Neurocognitive Disorders
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Alberta
Conditions:
HIV Associated Neurocognitive Disorder (HAND)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Th...
Detailed Description
This study is designed as a prospective, double-blinded pilot study of intranasal (IN) insulin versus placebo in people with HAND (n = 20) on stable ART medication. Participants will be randomly assig...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03277222
Start Date
November 1 2018
End Date
April 21 2019
Last Update
June 11 2020
Active Locations (1)
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1
Southern Alberta Clinic
Calgary, Alberta, Canada, T2R 0X7