ClinicalTrials.gg
CompletedNCT02431091OCT-HIVUpdated Mar 31, 2022

Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder

An interventional study of Optical Coherence Tomography in AIDS-Related Dementia Complex, sponsored by Centre Hospitalier Universitaire Saint Pierre. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Centre Hospitalier Universitaire Saint Pierre · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.

02

Conditions studied

  • AIDS-Related Dementia Complex

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Keywords

  • Optical Coherence Tomography
03

In context

AIDS Dementia Complex

41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.

This study's enrollment of 55 is close to the median of 50 across 31 interventional studies indexed under AIDS Dementia Complex.

Browse AIDS Dementia Complex studies →

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • infection
  • Antiretroviral treatment
  • Undetectable plasmatic HIV viral load (viral load\<50 copies/ml) for at least 6 months
  • Ability to understand and give approved consent

Exclusion criteria

Exclusion Criteria:

  • Any present or past ophthalmologic illness that may impair OCT results
  • Previous cerebral infection with sequel
  • Previous cerebrovascular disease with sequel
  • Severe psychiatric illness
  • Active alcohol or drug abuse
  • Active chronic
  • Inability to perform french cognitive assessment
  • Inability to perform a MRI
  • Inability to perform a lumbar puncture
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Definite Case

    Patients with abnormal response on both the screening questions and at least one of the cognitive screening tests. Optical Coherence Tomography is performed in all definite cases

    Other: Optical Coherence Tomography

  • Active comparator
    Control

    Patients with normal response on both the screening questions and all the cognitive screening tests. Optical Coherence Tomography is performed in matched control A patients

    Other: Optical Coherence Tomography

Interventions

  • OtherOptical Coherence Tomography

    Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina

06

What researchers measure

Primary outcomes

  1. Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation

    Time frame: Baseline

Secondary outcomes

  1. Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation

    Time frame: Baseline

  2. Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)

    Time frame: Baseline

07

Study locations

1 site
  • Hopital St Pierre
    Brussels, 1000, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Mar 2022, 83 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2015
First posted
Apr 30, 2015
StartActual
Apr 2015
Primary completionActual
Mar 2022
CompletionActual
Mar 2022
Last update
Mar 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02431091
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
Responsible party
Agnès Libois (Chef de Clinique, Centre Hospitalier Universitaire Saint Pierre) — Principal investigator
First posted
Apr 30, 2015
Start date
Apr 2015
Primary completion
Mar 2022
Completion
Mar 2022
Last update
Mar 31, 2022

Study contacts

Stéphane Dewit, PhD
study director · CHU St Pierre, Service des Maladies Infectieuses

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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