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

March 15, 2022 updated by: Agnès Libois, Centre Hospitalier Universitaire Saint Pierre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Hopital St Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina
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
Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Collaborators

Fonds iris-Recherche, Fondation Roi Baudouin, Belgium

Investigators

  • Study Director: Stéphane Dewit, PhD, CHU St Pierre, Service des Maladies Infectieuses

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUSTP-OCTHIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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