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Completed

NCT Number: NCT02431091

Evaluation of the Role of 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital St Pierre

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography

Other

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

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation

    Time frame: Baseline

  2. Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • Fonds iris-Recherche, Fondation Roi Baudouin, Belgium

Registry information

Official study title

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

Acronym: OCT-HIV

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2015
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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