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NCT03081117 · ClinicalTrials.gov registry record · Phase 1
Intranasal Insulin for the Treatment of HAND
A Phase 1 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03081117: Clinical Trial Phase 1 study, sponsored by Johns Hopkins University.
NCT03081117 is a Phase 1 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03081117, a Phase 1 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Number of documented serious adverse events per participant, mean
Interventions
- DRUG Placebo, intranasal
- DRUG Insulin, intranasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 1 |
Why NCT03081117 stopped before completion
NCT03081117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo, intranasal is the first listed.
NCT03081117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03081117 about?
NCT03081117 is a clinical study titled "Intranasal Insulin for the Treatment of HAND". 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 ...
What is the current status of trial NCT03081117?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-08-01. Estimated completion is 2020-10-16.
What interventions are being tested in trial NCT03081117?
The interventions under investigation include: Placebo, intranasal (DRUG), Insulin, intranasal (DRUG).
Who is sponsoring clinical trial NCT03081117?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03081117's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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