TerminatedPhase 1/2

Intranasal Insulin for the Treatment of HAND

Stopped: 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.

United States21 participantsStarted 2017-08-01

Plain-language 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.

Who can participate

Age range18 Years – 69 Years

SexALL

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

Inclusion Criteria: * Must have HIV, * Capable of providing informed consent, * Between the ages of 18-69 years, * Evidence of problems with memory, speed, and brain function, * Same HIV medications for at least 6 months (180 days) prior to study entry, with no plans to change the medications over the study period, * The following blood lab values within 2 weeks prior to study entry: hemoglobin \> 8.9 g/dl, absolute neutrophil count \> 500 cells/mm3, platelet count \> 50,000 cells/mm3, alanine aminotransferase (ALT) \< 2.5 X upper limit of normal, alkaline phosphatase \< 3 X upper limit of normal, serum creatinine ≤ 2 X upper limit of normal, * Negative pregnancy test (for women who could become pregnant), * Able and willing to use an intranasal device for taking the study drug without complications (e.g., no history of traumatic obstruction to nasal passage, chronic sinus infections, severe and symptomatic seasonal allergies, etc.), * Currently suppressed blood HIV viral load (undetectable or \<400 copies/mL). Exclusion Criteria: * Current or past opportunistic infection of the brain, * History or current clinical evidence of schizophrenia, * History of chronic neurological disorder, such as multiple sclerosis or uncontrolled epilepsy, * Active symptomatic AIDS defining opportunistic infection within 30 days prior to study entry, * History of an uncontrolled medical or psychiatric illness which in the opinion of the investigators would constitute a safety risk for patient…

What they're measuring

Serious Adverse Event Frequency

Timeframe: Total during 24-week trial

Serious Adverse Event Frequency, Participant Count

Timeframe: Total during 24-week trial

Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score

Timeframe: Difference between baseline and week 24 visits

Trial details

NCT IDNCT03081117

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-20

Results submitted2021-04-30

View on ClinicalTrials.gov More HIV Dementia trials

Intranasal Insulin for the Treatment of HAND

United States21 participantsStarted 2017-08-01

Plain-language summary

Who can participate

Age range18 Years – 69 Years

SexALL

See this in plain English?

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

What they're measuring

Serious Adverse Event Frequency

Timeframe: Total during 24-week trial

Serious Adverse Event Frequency, Participant Count

Timeframe: Total during 24-week trial

Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score

Timeframe: Difference between baseline and week 24 visits