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

AIDS-Related Dementia Complex Clinical Trial

— OCT-HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431091
• Other study ID #: CHUSTP-OCTHIV
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• AIDS Dementia Complex
• AIDS-Related Dementia Complex
• Neurocognitive Disorders

Intervention

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

Locations

Country	Name	City	State
Belgium	Hopital St Pierre	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Fonds iris-Recherche, Fondation Roi Baudouin, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation		Baseline
Secondary	Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation		Baseline
Secondary	Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)		Baseline