HIVFIRNNCT03596268
Functional Imaging Reserve in NeuroHIV
An observational study of HIV, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Imaging, Serum Laboratory Tests and Lumbar Puncture
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 30 Apr 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult persons living with HIV (PLWH) and demographically similar healthy HIV- controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. Results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in PLWH who have impaired neuropsychological performance.
Read the detailed description
This proposal systematically characterizes brain efficiency and recruitment in virologically suppressed persons living with HIV (PLWH) and demographically similar HIV uninfected (HIV-) controls. This proposal collects advanced functional neuroimaging that provide critical information about cerebral blood flow (CBF) and brain connectivity (functional connectivity strength; FCS); quantitative measures of immune dysfunction in the blood and cerebrospinal fluid (CSF) (immune activation and immune exhaustion); and neuropsychological performance testing. This overall goal of this proposal is to delineate the interplay between dysfunction in frontal networks and recruitment of compensatory networks that underlie the neuropsychiatric symptoms seen in PLWH.
- Conditions
- HIV
- Being tested
- Imaging, Serum Laboratory Tests, Lumbar Puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
3T Prisma MRI
Serum Laboratory TestsDiagnostic test
Blood (plasma and cellular) will be collected.
Lumbar PunctureDiagnostic test
CSF will be collected
| Study group | Role | What they receive |
|---|---|---|
| Persons Living with HIV (PLWH) | Persons 20-80 years old with a documented HIV infection for at least 1 year, who are on a stable cART medication regimen for at least 1 year, and have an undetectable plasma HIV RNA (<50 copies/ml). Receives: Diagnostic Test: Imaging; Diagnostic Test: Serum Laboratory Tests; Diagnostic Test: Lumbar Puncture | |
| HIV- Controls | Persons 20-80 years old with confirmed HIV- status matched to PLWH cohort with similar age, sex, education, and race. Receives: Diagnostic Test: Imaging; Diagnostic Test: Serum Laboratory Tests; Diagnostic Test: Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH.
The investigators will compare the recruitment of compensatory networks between the PLWH and HIV- controls using multiple linear regression. In exploratory analyses the investigators will compare the brain efficiency between PLWH and HIV-, using similar multiple regression models, controlling for confounders. Among PLWH, the investigators will study the association of brain efficiency with neuropsychological performance testing using multiple regression models.
Measured: 5 years
Secondary outcomes (1)
Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH.
The investigators will compare the recruitment (response) between the four HIV age groups (HIV- <50 year old, HIV- ≥50 years old, HIV+ <50 years old, and HIV+ ≥50 years old) using a multiple regression (ANCOVA) model, adjusting for potential confounders (age, sex, education, past substance use, and CVD). The pairwise comparisons of primary interest is between the HIV- <50 years old and the HIV- ≥50 years old groups. Among the PLWH only, the investigators will compare the brain efficiency r (response) between the younger and older group using multiple regression, adjusting for potential confounders. Secondly, a mediation analysis will examine the role of immune dysfunction (activation and exhaustion) markers as mediators of this relationship.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Nov 2018
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 284 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Missouri, St. Louis, Temple University, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Beau M Ances, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596268
- Sponsor's protocol ID
- 201805047
- Acronym
- FIRN
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2018
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data might be shared when the study has closed.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imaging Reserve in NeuroHIV
- ClinicalTrials.gov ID
- NCT03596268
- Acronym / sponsor ID
- FIRN / 201805047
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Missouri, St. Louis, Temple University, University of California, San Diego
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. Results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in PLWH who have impaired neuropsychological performance.
Detailed description
This proposal systematically characterizes brain efficiency and recruitment in virologically suppressed persons living with HIV (PLWH) and demographically similar HIV uninfected (HIV-) controls. This proposal collects advanced functional neuroimaging that provide critical information about cerebral blood flow (CBF) and brain connectivity (functional connectivity strength; FCS); quantitative measures of immune dysfunction in the blood and cerebrospinal fluid (CSF) (immune activation and immune exhaustion); and neuropsychological performance testing. This overall goal of this proposal is to delineate the interplay between dysfunction in frontal networks and recruitment of compensatory networks that underlie the neuropsychiatric symptoms seen in PLWH.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons Living with HIV (PLWH) | – | Diagnostic Test: Imaging, Diagnostic Test: Serum Laboratory Tests, Diagnostic Test: Lumbar PuncturePersons 20-80 years old with a documented HIV infection for at least 1 year, who are on a stable cART medication regimen for at least 1 year, and have an undetectable plasma HIV RNA (<50 copies/ml). |
| HIV- Controls | – | Diagnostic Test: Imaging, Diagnostic Test: Serum Laboratory Tests, Diagnostic Test: Lumbar PuncturePersons 20-80 years old with confirmed HIV- status matched to PLWH cohort with similar age, sex, education, and race. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult persons living with HIV (PLWH) and demographically similar healthy HIV- controls
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Imaging3T Prisma MRI | Diagnostic test | HIV- Controls, Persons Living with HIV (PLWH) |
| Serum Laboratory TestsBlood (plasma and cellular) will be collected. | Diagnostic test | HIV- Controls, Persons Living with HIV (PLWH) |
| Lumbar PunctureCSF will be collected | Diagnostic test | HIV- Controls, Persons Living with HIV (PLWH) |
Primary outcome
Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH.
Time frame: 5 years
The investigators will compare the recruitment of compensatory networks between the PLWH and HIV- controls using multiple linear regression. In exploratory analyses the investigators will compare the brain efficiency between PLWH and HIV-, using similar multiple regression models, controlling for confounders. Among PLWH, the investigators will study the association of brain efficiency with neuropsychological performance testing using multiple regression models.
1 secondary outcome
Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH.
Time frame: 5 years
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 29 Aug 2025.
- Individual participant dataSharing planned: Undecided. Data might be shared when the study has closed.
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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 M Ances, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Washington University School of Medicine 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 7 inclusion and 8 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 29 Aug 2025. 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.
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?
Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH. (time frame: 5 years). 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 29 Aug 2025.