Examining brain function in people living with HIV
Functional Imaging Reserve in NeuroHIV
Washington University School of Medicine · NCT03596268
This study is trying to see how the brains of people living with HIV work to make up for thinking difficulties, comparing them to people without HIV to understand any links to mental health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | cART |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03596268 on ClinicalTrials.gov |
What this trial studies
This research investigates how the brain of individuals living with HIV compensates for cognitive deficits, particularly focusing on the frontal regions. It employs advanced functional neuroimaging techniques to assess cerebral blood flow and brain connectivity, alongside immune function measures and neuropsychological testing. By comparing virologically suppressed individuals with HIV to similar HIV-negative controls, the study aims to uncover the relationship between brain dysfunction and neuropsychiatric symptoms in this population.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 20 to 80 with documented HIV infection on stable treatment or HIV-negative individuals with at least 9 years of education.
Not a fit: Patients with significant neurological disorders, active psychiatric conditions, or contraindications to MRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and potential interventions for cognitive impairments in people living with HIV.
How similar studies have performed: Other studies have shown promise in understanding brain function in HIV, but this specific approach may provide novel insights into compensatory mechanisms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 20 to 80 years old * documented HIV infection for at least 1 year or confirmed HIV - status * PLWH must be on stable cART regimen for at least 12 months with undetectable plasma HIV RNA (less than 50 copies per mL) * at least 9 years of education * able to provide informed consent * if female, a negative pregnancy test and not breast feeding * able to undergo an MRI scan Exclusion Criteria: * significant neurological disorders (e.g. stroke, head injury with loss of consciousness for more than 5 minutes, developmental learning disability) * active uncontrolled Axis I psychiatric disorder according to the DSM 5 * current or history of substance use disorder (including, but not limited to amphetamines, cocaine, alcohol, opiates, and barbiturates) * prescribed blood thinners * allergic to lidocaine or similar anesthetic * history of any bleeding disorder * contraindication to MRI scanning (e.g. claustrophobia, pacemaker, etc.) * pregnant or breastfeeding
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Beau M Ances, MD, PhD — Washington University School of Medicine
- Study coordinator: Regina Thompson, BS
- Email: thompson.r@wustl.edu
- Phone: 3147478421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV