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Evaluation 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
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for AIDS-Related Dementia Complex focused on measuring Optical Coherence Tomography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 22, 2015
Last Updated
March 15, 2022
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
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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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