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

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

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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