Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02678767
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02678767
Study Brief:
Protocol Section:
NCT02678767