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.
Clinical Trial of Intranasal Insulin for the Treatment of HIV-associated Neurocognitive Disorder (HAND)
Sponsor study identifier
interventional
21
1 country
1
Study Start
August 1, 2017
Actual (reported)Primary Completion
May 20, 2020
Actual (reported)Study Completion
October 16, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 16, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2017
Actual (reported)March 16, 2017
Actual (reported)August 1, 2017
Actual (reported)May 20, 2020
Actual (reported)October 16, 2020
Actual (reported)July 7, 2021
Actual (reported)Serious Adverse Event Frequency
Number of documented serious adverse events per participant, mean
Total during 24-week trial
Serious Adverse Event Frequency, Participant Count
Number participants with at least one documented serious adverse event, count
Total during 24-week trial
Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score
Change in GDS, measured at two time points, baseline and Week 24 visits. GDS is a composite score based on neurocognitive test performance. The 14 data points that comprise the GDS include Hopkins Verbal Learning Test (trials 1-3 total score and delayed recall), Rey Complex Figure Test (copy and delayed recall), WAIS symbol-digit test, grooved pegboard (dominant and non-dominant), CalCAP (Choice reaction time and Sequential reaction time), Trail-making Test (Parts A and B), Stroop Color Interference Test (trial 3), timed gait (3 trials average), and verbal fluency (FAS). Raw scores were transformed to t-scores using age/education stratified normative data, then assigned a discrete value from 0 to 5 using the following t-score categorization: \> or = 40 is '0', 35.00 to 39.99 is '1', 30.00 to 34.99 is '2', 25.00 to 29.99 is '3', 20.00 to 24.99 is '4', and \<20 is '5'. The 14 individual scores were then averaged. A higher GDS is a worse outcome (0 = no deficits and 5 = maximum deficits).
Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
Difference between baseline and week 24 visits
CSF Biomarkers, Week 24 Visit Value Minus Baseline Value
Between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Changes between baseline and week 24 visits
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Regular insulin administered by specialized, non-commercial intranasal drug delivery device
Saline solution administered by specialized, non-commercial intranasal drug delivery device
The Johns Hopkins Institute for Clinical and Translational Research, Adult Outpatient Clinical Research Unit
Baltimore, Maryland, 21287, United States
Leah Rubin, PhD
Johns Hopkins University
21 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2017
First Posted
March 16, 2017
Study Start
August 1, 2017
Actual (reported)Maraviroc and NeuroAIDS Pathogenesis
Ferumoxytol-enhanced Brain MRI in HIV-associated Neurocognitive Disorders
Difference between baseline and week 24 visits
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 20, 2020
Actual (reported)Study Completion
October 16, 2020
Actual (reported)Last Updated
July 7, 2021
Results First Posted
July 7, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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