Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT02678767
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015526', 'term': 'AIDS Dementia Complex'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the proportion of abnormal MRIs', 'timeFrame': 'Change from Baseline MRI at 4-6 weeks post-infusion MRI', 'description': 'The proportion of abnormal MRIs will be compared for each group.'}], 'secondaryOutcomes': [{'measure': 'Change in quantitative susceptibility mapping (QSM)', 'timeFrame': 'Change from Baseline MRI at 4-6 weeks post-infusion MRI', 'description': 'Use of QSM to quantitate ferumoxytol accumulation in the brain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Dementia', 'Neuroimaging'], 'conditions': ['AIDS Dementia Complex']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 40-65 years\n* Plasma HIV RNA \\< 48 copies/ml (HIV+ subjects only)\n* On stable cART \\>= 1 year (HIV+ subjects only)\n* Global neuropsychological (NP) score \\<-0.5 in at least one cognitive domain known to be affected by HIV (neurocognitively impaired subjects only)\n* Documentation of negative HIV infection by an FDA approved test (HIV- subjects only)\n\nExclusion Criteria:\n\n* Active substance use\n* History of myocardial infarct or stroke\n* Diabetes\n* Chronic hepatitis C virus (HCV) infection\n* 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\n* Psychoactive or other medications which may impact NP testing\n* Factors that preclude MRI\n* Known hypersensitivity to ferumoxytol\n* History of laboratory measurements consistent with an iron overload syndrome\n* Medical conditions that require frequent blood transfusions\n* Taking oral iron supplements\n* Elevated iron levels\n* Any condition, which in the opinion of the investigator, would compromise the subject's ability to participate\n* Multiple drug allergies that may pose a greater risk of anaphylaxis associated with ferumoxytol\n* Pregnant, unwillingness to practice birth control, or breastfeeding\n* Unable to give informed consent"}, 'identificationModule': {'nctId': 'NCT02678767', 'briefTitle': 'Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS', 'orgStudyIdInfo': {'id': '2013-077'}, 'secondaryIdInfos': [{'id': 'H032', 'type': 'OTHER', 'domain': 'Hawaii Center for AIDS'}, {'id': '1R21NS087951-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21NS087951-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV+ with neurocognitive disorder', 'description': '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', 'interventionNames': ['Drug: Ferumoxytol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV+ without neurocognitive impairment', 'description': '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', 'interventionNames': ['Drug: Ferumoxytol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV- without neurocognitive impairment', 'description': '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', 'interventionNames': ['Drug: Ferumoxytol']}], 'interventions': [{'name': 'Ferumoxytol', 'type': 'DRUG', 'otherNames': ['Feraheme'], 'description': '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', 'armGroupLabels': ['HIV+ with neurocognitive disorder', 'HIV+ without neurocognitive impairment', 'HIV- without neurocognitive impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Center for AIDS', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Beau Nakamoto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hawaii'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beau Nakamoto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hawaii Pacific Health', 'class': 'OTHER'}, {'name': 'University of Hawaii', 'class': 'OTHER'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Beau Nakamoto', 'investigatorAffiliation': 'University of Hawaii'}}}}