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Clinical Trials/NCT02431091
NCT02431091
Completed
Not Applicable

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

Centre Hospitalier Universitaire Saint Pierre1 site in 1 country55 target enrollmentApril 2015
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ConditionsAIDS-Related Dementia Complex

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
AIDS-Related Dementia Complex
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Enrollment
55
Locations
1
Primary Endpoint
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
March 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible Party
Principal Investigator
Principal Investigator

Agnès Libois

Chef de Clinique

Centre Hospitalier Universitaire Saint Pierre

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline

Secondary Outcomes

  • 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 Sites (1)

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