Back to resultsEvaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder (OCT-HIV)
Primary Purpose
AIDS-Related Dementia Complex
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Optical Coherence Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for AIDS-Related Dementia Complex focused on measuring Optical Coherence Tomography
Eligibility Criteria
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
Sites / Locations
- Hopital St Pierre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Definite Case
Control
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
Secondary Outcome Measures
Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation
Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)
Full Information
NCT ID
NCT02431091
First Posted
April 22, 2015
Last Updated
March 15, 2022
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT02431091
Brief Title
Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder
Acronym
OCT-HIV
Official Title
Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS-Related Dementia Complex
Keywords
Optical Coherence Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Definite Case
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Optical Coherence Tomography
Intervention Description
Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina
Primary Outcome Measure Information:
Title
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation
Time Frame
Baseline
Title
Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Dewit, PhD
Organizational Affiliation
CHU St Pierre, Service des Maladies Infectieuses
Official's Role
Study Director
Facility Information:
Facility Name
Hopital St Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder
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