- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678767
Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
October 25, 2017 updated by: Beau Nakamoto
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Hawaii Center for AIDS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIV+ with neurocognitive disorder
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
|
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
Other Names:
|
Active Comparator: HIV+ without neurocognitive impairment
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
|
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
Other Names:
|
Active Comparator: HIV- without neurocognitive impairment
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline MRI at 4-6 weeks post-infusion MRI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quantitative susceptibility mapping (QSM)
Time Frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI
|
Use of QSM to quantitate ferumoxytol accumulation in the brain
|
Change from Baseline MRI at 4-6 weeks post-infusion MRI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Beau Nakamoto, MD, PhD, University of Hawaii
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
February 2, 2016
First Submitted That Met QC Criteria
February 5, 2016
First Posted (Estimate)
February 10, 2016
Study Record Updates
Last Update Posted (Actual)
October 27, 2017
Last Update Submitted That Met QC Criteria
October 25, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neurocognitive Disorders
- HIV Infections
- Dementia
- AIDS Dementia Complex
- Hematinics
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Ferrosoferric Oxide
Other Study ID Numbers
- 2013-077 (CCRRC)
- H032 (Other Identifier: Hawaii Center for AIDS)
- 1R21NS087951-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on AIDS Dementia Complex
-
University Hospital, Basel, SwitzerlandTerminatedAIDS-related Dementia ComplexSwitzerland
-
National Institute of Mental Health (NIMH)TerminatedHIV Infections | Healthy | AIDS Dementia Complex | AIDS-Related Dementia Complex | HIV-Associated Cognitive Motor Complex | HIV-Dementia | AIDS EncephalopathyUnited States
-
Centre Hospitalier Universitaire Saint PierreFonds iris-Recherche, Fondation Roi Baudouin, BelgiumCompletedAIDS-Related Dementia ComplexBelgium
-
Johns Hopkins UniversityTerminatedHIV Dementia | HIV-Associated Cognitive Motor ComplexUnited States
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA)CompletedHIV Associated Cognitive Motor ComplexUnited States
-
National Institutes of Health Clinical Center (CC)CompletedDepression | HIV Infections | HIV-Associated Cognitive Motor ComplexUnited States
-
Holdsworth House Medical PracticeCompletedHIV-1-Associated Cognitive Motor Complex
-
National Institute of Mental Health (NIMH)TerminatedHIV-Associated Cognitive Motor ComplexUnited States
-
Universidad Nacional Autonoma de MexicoRecruitingTelerehabilitation | Neuropsychology | HIV DementiaMexico
-
University of Alabama, TuscaloosaUAB Resource Centers for Minority Aging Research (RCMAR)Unknown
Clinical Trials on Ferumoxytol
-
Michael IvNational Cancer Institute (NCI)WithdrawnChildhood Brain NeoplasmUnited States
-
Allegheny Singer Research Institute (also known...Active, not recruitingLiver Neoplasms | Hepatocellular Carcinoma | Liver Metastases | Liver Cancer | Liver Carcinoma | Hepatocellular Cancer | Hepatic Cirrhosis | Hepatic Carcinoma | Hepatic AtrophyUnited States
-
Massachusetts General HospitalCompletedPapillary Carcinoma of Thyroid Gland | Metastatic Medullary Thyroid Cancer | Follicular Thyroid Cancer Lymph Node MetastasisUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Radiological Society of North AmericaTerminatedStage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Locally Advanced Rectal CarcinomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science University; National... and other collaboratorsRecruitingPancreatic Adenocarcinoma | Familial Pancreatic Cancer | Pancreatic Intraductal Papillary-Mucinous NeoplasmUnited States
-
Michael IvCompletedBrain Injury | Brain Cancer | Brain Tumors | Primary Brain Neoplasm | Ischemic Cerebrovascular Accident | Central Nervous System Degenerative Disorder | Central Nervous System Infectious Disorder | Central Nervous System Vascular Malformation | Hemorrhagic Cerebrovascular AccidentUnited States
-
Dana-Farber Cancer InstituteWithdrawn
-
AMAG Pharmaceuticals, Inc.UnknownPeripheral Arterial Disease (PAD)United States
-
National Cancer Institute (NCI)CompletedProstate CancerUnited States
-
University of EdinburghRoyal Brompton & Harefield NHS Foundation Trust; Royal Infirmary of Edinburgh; Golden Jubilee National HospitalCompletedMyocarditis | Healthy Volunteers | Cardiac Transplant | Cardiac SarcoidUnited Kingdom