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

C

Centre Hospitalier Universitaire Saint Pierre

Status

Completed

Conditions

AIDS-Related Dementia Complex

Treatments

Other: Optical Coherence Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT02431091
CHUSTP-OCTHIV

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

55 participants in 2 patient groups

Definite Case
Experimental group
Description:
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
Treatment:
Other: Optical Coherence Tomography
Control
Active Comparator group
Description:
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
Treatment:
Other: Optical Coherence Tomography

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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