HIV DementiaPhase 1/2NCT03081117
Intranasal Insulin for the Treatment of HAND
A Phase 1/2 study testing Insulin, intranasal in people with HIV Dementia and HIV-Associated Cognitive Motor Complex, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- HIV Dementia, HIV-Associated Cognitive Motor Complex
- What is being tested?
- Insulin, intranasal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 16 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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).
Who cannot join
- 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 patients or interfere with the ability of a participant to complete the study,
- History of diabetes or treatment with insulin or an oral hypoglycemic agent,
Show all 11Show fewer
- Amylase/lipase elevation (≥ 2 X upper limit of normal) within 14 days prior to starting study drug,
- Detectable plasma HIV RNA test ≥400 copies/mL within 6 months prior to baseline/randomization,
- History of any endocrine related cancer, including any thyroid tumor,
- Current use of cocaine, heroin, or methamphetamine. Current use will be defined and determined by any evidence of such use within the two years (730 days) prior to study enrollment; evidence includes but is not limited to urine drug toxicology testing by the study team at screening and pre-entry visits,
- Presence of other conditions that significantly affect and complicate performance on neurocognitive tests (such as, learning disabilities, history of severe alcohol abuse, head injury with trauma to the brain and loss of consciousness >30 minutes).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Institute for Clinical and Translational Research, Adult Outpatient Clinical Research Unit
Baltimore, Maryland, 21287
About this study
Official title: Clinical Trial of Intranasal Insulin for the Treatment of HIV-associated Neurocognitive Disorder (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 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.
Read more
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.
Read the detailed description
HIV-associated neurocognitive disorders (HAND) are characterized by disabling cognitive, behavioral, and motor dysfunction and can occur in individuals with HIV even while taking combination antiretroviral therapy (ART). The mechanisms for these residual impairments are not fully understood, but appear to involve poor penetrance of ART drugs into the central nervous system (CNS) and the resulting brain sanctuary for inadequately suppressed HIV infection with associated sustained inflammation. Adjunctive therapies with targeted neuroprotective agents are critically needed for the treatment of HAND. Insulin is involved in multiple CNS functions including food intake, metabolism, learning, and memory. Insulin has neuroprotective properties demonstrated in cell culture experiments and in vivo models, which provide strong evidence for its use as a therapeutic agent to treat HAND.
Insulin modifying therapy (IMT) includes intranasal insulin administered by a novel nasal drug delivery device. IMT may play important roles in neuronal plasticity and survival by protecting hippocampal neurons against oxidative stress and apoptotic cell death induced by glutamate neurotoxicity. Previous studies support the proposed early phase trial of IMT as a novel therapeutic agent for HAND.
This double-blinded placebo-controlled clinical trial evaluates safety of intranasal insulin at the daily dose of 40 IU and will provide initial data for assessing safety and efficacy. The protocol measures safety by incidence and frequency of adverse events. Clinical effects of IMT over the 24-week trial period are measured by change in neurocognitive and functional testing results, as well as several novel radiological and cerebrospinal fluid (CSF) surrogate markers. Outcomes from these studies could have important implications for the design of future studies with IMT and other neuroprotective compounds for HAND.
- Being tested
- Insulin, intranasal, Placebo, intranasal
- Keywords
- HIV-Associated Neurocognitive Disorder (HAND), Intranasal
- Medical subject headings
- AIDS Dementia Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin, intranasalDrug
Also called Novolin R
Regular insulin administered by specialized, non-commercial intranasal drug delivery device
Placebo, intranasalDrug
Saline solution administered by specialized, non-commercial intranasal drug delivery device
| Study group | Role | What they receive |
|---|---|---|
| Insulin, intranasal | Experimental | Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose Receives: Drug: Insulin, intranasal |
| Placebo, intranasal | Placebo comparator | Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose Receives: Drug: Placebo, intranasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Event Frequency
Number of documented serious adverse events per participant, mean
Measured: Total during 24-week trial
Serious Adverse Event Frequency, Participant Count
Number participants with at least one documented serious adverse event, count
Measured: 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).
Measured: Difference between baseline and week 24 visits
Secondary outcomes (11)
Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
NPZ-8 score at 24 weeks minus baseline NPZ-8 score: The NPZ-8 is an average of 8 individual Z-scores, where higher values indicate greater neurocognitive performance (better outcome). The NPZ-8 represents the number of standard deviations an individual's performance is away from the mean (Z-score = 0) of age and education matched reference populations where performance worse than the mean had negative Z-scores (i.e. Z-scores were inverted for tests scored on speed). The NPZ-8 average is comprised of 8 data points from 6 tests: timed gait, WAIS symbol-digit, grooved pegboard dominant \& non-dominant, CalCAP Choice \& Sequential reaction times, and the Trail-making Test parts A \& B. Raw scores were transformed to Z-scores for each test and then averaged to calculate the NPZ-8 score at each visit (Z-scores +/-3.5 standard deviations from mean limited to +/-3.5). Positive change in NPZ-8 from baseline to Week 24 indicated improved performance and negative change indicated worse performance.
Measured: Difference between baseline and week 24 visits
CSF Biomarkers, Week 24 Visit Value Minus Baseline Value
Changes in cerebrospinal fluid (CSF) concentrations of ceramide, sphingomyelin, citrate, neurofilament protein; brain-derived neurotrophic factor (BDNF), protein carbonyl, Aβ-42
Measured: Between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in the basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value
Diffusion tensor imaging (DTI), change in whole brain fractional anisotropy (FA) between baseline and 24 weeks. FA is a unitless index that is used for measuring diffusion asymmetry. FA values range from 0 to 1 (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1). FA was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean FA = (Sum of (each ROI's FA * volume)) / (Sum of all ROI volumes).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value
Diffusion weighted imaging, change in whole brain mean diffusivity (MD) between baseline and 24 weeks. MD was measured as the mean of three eigenvalues and has the unit m^2/s. Higher values indicate greater diffusivity. MD was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean MD = (Sum of (each ROI's MD * volume)) / (Sum of all ROI volumes).
Measured: Changes between baseline and week 24 visits
Neuroimaging Markers: ASL, Week 24 Visit Value Minus Baseline Value
Arterial spin labeling (ASL), a novel measure of cerebral blood flow
Measured: Changes between baseline and week 24 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Aug 2017
- Primary completion20 May 2020
- Study completion16 Oct 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV DementiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leah Rubin, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081117
- Sponsor's protocol ID
- IRB00108564
- Status last verified
- Jun 2021
- First submitted
- 9 Mar 2017
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Intranasal Insulin for the Treatment of HIV-associated Neurocognitive Disorder (HAND)
- ClinicalTrials.gov ID
- NCT03081117
- Acronym / sponsor ID
- IRB00108564
- Keywords
- HIV-Associated Neurocognitive Disorder (HAND), Intranasal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HIV-associated neurocognitive disorders (HAND) are characterized by disabling cognitive, behavioral, and motor dysfunction and can occur in individuals with HIV even while taking combination antiretroviral therapy (ART). The mechanisms for these residual impairments are not fully understood, but appear to involve poor penetrance of ART drugs into the central nervous system (CNS) and the resulting brain sanctuary for inadequately suppressed HIV infection with associated sustained inflammation. Adjunctive therapies with targeted neuroprotective agents are critically needed for the treatment of HAND. Insulin is involved in multiple CNS functions including food intake, metabolism, learning, and memory. Insulin has neuroprotective properties demonstrated in cell culture experiments and in vivo models, which provide strong evidence for its use as a therapeutic agent to treat HAND.
Insulin modifying therapy (IMT) includes intranasal insulin administered by a novel nasal drug delivery device. IMT may play important roles in neuronal plasticity and survival by protecting hippocampal neurons against oxidative stress and apoptotic cell death induced by glutamate neurotoxicity. Previous studies support the proposed early phase trial of IMT as a novel therapeutic agent for HAND.
This double-blinded placebo-controlled clinical trial evaluates safety of intranasal insulin at the daily dose of 40 IU and will provide initial data for assessing safety and efficacy. The protocol measures safety by incidence and frequency of adverse events. Clinical effects of IMT over the 24-week trial period are measured by change in neurocognitive and functional testing results, as well as several novel radiological and cerebrospinal fluid (CSF) surrogate markers. Outcomes from these studies could have important implications for the design of future studies with IMT and other neuroprotective compounds for HAND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Insulin, intranasal | Experimental | Drug: Insulin, intranasalRegular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose |
| Placebo, intranasal | Placebo comparator | Drug: Placebo, intranasalSaline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (11 listed)
- 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 patients or interfere with the ability of a participant to complete the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin, intranasalAlso: Novolin RRegular insulin administered by specialized, non-commercial intranasal drug delivery device | Drug | Insulin, intranasal |
| Placebo, intranasalSaline solution administered by specialized, non-commercial intranasal drug delivery device | Drug | Placebo, intranasal |
Primary outcome
Serious Adverse Event Frequency
Time frame: Total during 24-week trial
Number of documented serious adverse events per participant, mean
Serious Adverse Event Frequency, Participant Count
Time frame: Total during 24-week trial
Number participants with at least one documented serious adverse event, count
Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score
Time frame: Difference between baseline and week 24 visits
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).
11 secondary outcomes
Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
Time frame: Difference between baseline and week 24 visits
CSF Biomarkers, Week 24 Visit Value Minus Baseline Value
Time frame: Between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: ASL, Week 24 Visit Value Minus Baseline Value
Time frame: Changes between baseline and week 24 visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for HIV Dementia
RecruitingPhase 1/2
SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
HIV Associated Neurocognitive Disorder, HIV Dementia
Not yet recruiting
The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV
Insomnia, Cognition
RecruitingObservational study
ALS Research Collaborative
Amyotrophic Lateral Sclerosis, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Rubin, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Insulin, intranasal in people with HIV Dementia and HIV-Associated Cognitive Motor Complex, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Event Frequency (time frame: Total during 24-week trial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.