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

NCT02431091 | Completed

• 1 other identifier: CHUSTP-OCTHIV
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS-Related Dementia Complex

Keywords

Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (2)

• 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

Study Arms (2)

Definite Case

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Optical Coherence Tomography OTHER

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

Control; Definite Case

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Fonds iris-Recherche, Fondation Roi Baudouin, Belgium: collaborator

Study Sites (1)

Hopital St Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

AIDS Dementia Complex

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Stéphane Dewit, PhD

  CHU St Pierre, Service des Maladies Infectieuses

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de Clinique

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 30, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

BE (1)