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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder

Conditions
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AIDS-Related Dementia Complex

Intervention / Treatment
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* Other: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV 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: 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 hepatitis C Inability to perform french cognitive assessment Inability to perform a MRI Inability to perform a lumbar puncture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definite Case<br>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<br>* Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina<br>|
| Active Comparator: Control<br>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<br>* Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation |  | Baseline | 
| Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Coherence Tomography