drugset
drugset / Trial / NCT03081117

Intranasal Insulin for the Treatment of HAND

NCT03081117 ↗

Phase 1/2 Terminated 21 enrolled Johns Hopkins University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Infection with HIV (the virus that causes AIDS) can lead to problems with brain function, such as memory, concentration, judgment, and the speed or control of hands and legs. Neurologists have called this condition HIV-associated neurocognitive disorder (HAND). This research is being done to see if insulin taken through the nose as a spray (intranasal insulin) can help people with HIV who are having problems with memory and brain function, or HAND. Participants will be given either insulin or placebo. A placebo is an inactive substance that looks like the study drug, but does not contain study drug. For this research study, the placebo will be a clear, saline-based liquid spray that looks like the insulin spray but has no insulin. Participants will not be told whether they receive insulin or placebo during the study. All participants will take the intranasal spray twice a day, about 30 minutes after a meal. Participants will use a specialized intranasal drug administration device. The total daily dose of insulin is 40 IU split between 20 IU in the morning and 20 IU in the evening. Participants will take the intranasal spray for 24 weeks. The researchers will record symptoms and side effects during the study. Procedures include neurocognitive testing of memory and brain function, two optional lumbar punctures ("spinal taps"), two MRI brain scans, monthly blood draws, and clinical assessments.

Timeline

Start
2017-08-01
Primary completion
2020-05-20
Completion
2020-10-16

Outcome

Mixed primary results

Stopped (Enrollment): “On 3/15/2020 study visits were suspended due to COVID-19 pandemic. With safety concerns surrounding COVID-19 and difficulty recruiting, the investigators decided to close enrollment 10/16/2020 after interim data were reviewed by the DSMB and NIH.”

registry analysis (superiority test); Insulin, Intranasal vs Placebo, Intranasal; p = 0.669; Fisher Exact NCT03081117 ↗

registry analysis (superiority test); Insulin, Intranasal vs Placebo, Intranasal; p = 0.0366; Mean Difference (Net) -0.3914; t-test, 2 sided NCT03081117 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 20 iu Intranasal

Indications

AIDS dementia complex