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

Not Applicable

Completed

• Conditions: AIDS-Related Dementia Complex
• Interventions: Other: Optical Coherence Tomography

• Registration Number: NCT02431091
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-30
• Status Verified: 2022-03
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Optical Coherence Tomography	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
Definite Case	Optical Coherence Tomography	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

Primary Outcome Measures

Name	Time	Method
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation	Baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital St Pierre; 🇧🇪 Brussels, Belgium