AIDS Dementia ComplexPhase 2NCT02678767
Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
A Phase 2 study testing Ferumoxytol in people with AIDS Dementia Complex, run by Beau Nakamoto at 1 site in United States.
Trial summary
This project will investigate the ability of a novel MRI contrast agent to identify and quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of HIV-infected individuals. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- AIDS Dementia Complex
- What is being tested?
- Ferumoxytol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-65 years
- Plasma HIV RNA < 48 copies/ml (HIV+ subjects only)
- On stable cART >= 1 year (HIV+ subjects only)
- Global neuropsychological (NP) score <-0.5 in at least one cognitive domain known to be affected by HIV (neurocognitively impaired subjects only)
- Documentation of negative HIV infection by an FDA approved test (HIV- subjects only)
Who cannot join
- Active substance use
- History of myocardial infarct or stroke
- Diabetes
- Chronic hepatitis C virus (HCV) infection
- Uncontrolled major affective disorder, active psychosis, central nervous system disease that affects the brain structure, or other uncontrolled chronic medical condition that in the opinion of the investigator may impact NP testing or the study outcome
- Psychoactive or other medications which may impact NP testing
Show all 16Show fewer
- Factors that preclude MRI
- Known hypersensitivity to ferumoxytol
- History of laboratory measurements consistent with an iron overload syndrome
- Medical conditions that require frequent blood transfusions
- Taking oral iron supplements
- Elevated iron levels
- Any condition, which in the opinion of the investigator, would compromise the subject's ability to participate
- Multiple drug allergies that may pose a greater risk of anaphylaxis associated with ferumoxytol
- Pregnant, unwillingness to practice birth control, or breastfeeding
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS
This project will investigate the ability of a novel MRI contrast agent to identify and quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of HIV-infected individuals.
Read the detailed description
HIV-associated neurocognitive disorders (HAND) continue to be prevalent despite effective combination antiretroviral therapy (cART) and have a significant impact on morbidity and quality of life. Monocytes/macrophages (M/MΦ) are believed to play a critical role in the pathogenesis of HAND. Neuroimaging HIV research has not focused on assessing M/MΦ-mediated inflammation in the brain. Currently, no neuroimaging modality exists that can define the extent of active inflammation due to M/MΦ in HAND either as a clinical diagnostic tool or to assist in defining objective improvement in clinical trials addressing HAND. Ferumoxytol is an ultra-small iron oxide MRI contrast agent avidly taken up by circulating M/MΦ. The investigators hypothesize that ferumoxytol-based imaging can identify ongoing inflammation due to perivascular M/MΦ which is believed to represent a key pathologic correlate of HAND.
- Conditions
- AIDS Dementia Complex
- Being tested
- Ferumoxytol
- Keywords
- HIV, Dementia, Neuroimaging
- Medical subject headings
- AIDS Dementia Complex, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme
All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion
| Study group | Role | What they receive |
|---|---|---|
| HIV+ with neurocognitive disorder | Experimental | All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion Receives: Drug: Ferumoxytol |
| HIV+ without neurocognitive impairment | Active comparator | All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion Receives: Drug: Ferumoxytol |
| HIV- without neurocognitive impairment | Active comparator | All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of abnormal MRIs
The proportion of abnormal MRIs will be compared for each group.
Measured: Change from Baseline MRI at 4-6 weeks post-infusion MRI
Secondary outcomes (1)
Change in quantitative susceptibility mapping (QSM)
Use of QSM to quantitate ferumoxytol accumulation in the brain
Measured: Change from Baseline MRI at 4-6 weeks post-infusion MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS Dementia ComplexStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beau Nakamoto
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaii Pacific Health, University of Hawaii, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Beau Nakamoto, University of Hawaii
- Investigators
- Beau Nakamoto, MD, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678767
- Sponsor's protocol ID
- 2013-077
- Other IDs
- H032, 1R21NS087951-01A1
- Status last verified
- Oct 2017
- First submitted
- 2 Feb 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS
- ClinicalTrials.gov ID
- NCT02678767
- Acronym / sponsor ID
- 2013-077
- Conditions
- AIDS Dementia Complex
- Keywords
- HIV, Dementia, Neuroimaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beau NakamotoUniversity, hospital or other
- Collaborators
- Hawaii Pacific Health, University of Hawaii, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will investigate the ability of a novel MRI contrast agent to identify and quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of HIV-infected individuals.
Detailed description
HIV-associated neurocognitive disorders (HAND) continue to be prevalent despite effective combination antiretroviral therapy (cART) and have a significant impact on morbidity and quality of life. Monocytes/macrophages (M/MΦ) are believed to play a critical role in the pathogenesis of HAND. Neuroimaging HIV research has not focused on assessing M/MΦ-mediated inflammation in the brain. Currently, no neuroimaging modality exists that can define the extent of active inflammation due to M/MΦ in HAND either as a clinical diagnostic tool or to assist in defining objective improvement in clinical trials addressing HAND. Ferumoxytol is an ultra-small iron oxide MRI contrast agent avidly taken up by circulating M/MΦ. The investigators hypothesize that ferumoxytol-based imaging can identify ongoing inflammation due to perivascular M/MΦ which is believed to represent a key pathologic correlate of HAND.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV+ with neurocognitive disorder | Experimental | Drug: FerumoxytolAll subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion |
| HIV+ without neurocognitive impairment | Active comparator | Drug: FerumoxytolAll subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion |
| HIV- without neurocognitive impairment | Active comparator | Drug: FerumoxytolAll subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-65 years
- Plasma HIV RNA < 48 copies/ml (HIV+ subjects only)
- On stable cART >= 1 year (HIV+ subjects only)
- Global neuropsychological (NP) score <-0.5 in at least one cognitive domain known to be affected by HIV (neurocognitively impaired subjects only)
- Documentation of negative HIV infection by an FDA approved test (HIV- subjects only)
Key exclusion criteria (16 listed)
- Active substance use
- History of myocardial infarct or stroke
- Diabetes
- Chronic hepatitis C virus (HCV) infection
- Uncontrolled major affective disorder, active psychosis, central nervous system disease that affects the brain structure, or other uncontrolled chronic medical condition that in the opinion of the investigator may impact NP testing or the study outcome
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 |
|---|---|---|
| FerumoxytolAlso: FerahemeAll subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion | Drug | HIV+ with neurocognitive disorder, HIV+ without neurocognitive impairment, HIV- without neurocognitive impairment |
Primary outcome
Change in the proportion of abnormal MRIs
Time frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI
The proportion of abnormal MRIs will be compared for each group.
1 secondary outcome
Change in quantitative susceptibility mapping (QSM)
Time frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Beau Nakamoto, MD, PhD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferumoxytol in people with AIDS Dementia Complex, run by Beau Nakamoto 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 27 Oct 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the proportion of abnormal MRIs (time frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI). 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 27 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.