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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients

NCT03279835

HIV-1

COMPLETED

COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old

NCT03268109

Memory Impairment HIV/AIDS Cognitive Impairment

COMPLETED

Prevalence of HIV-associated Neurocognitive Disorders (HAND) in a School of Medicine HIV/AIDS Outpatient Clinic

NCT02187796

HIV-ASSOCIATED NEUROCOGNITIVE DISORDER (HAND)

COMPLETED

Ferumoxytol-enhanced Brain MRI in HIV-associated Neurocognitive Disorders

NCT01665846

HIV Dementia

COMPLETED PHASE1

Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

NCT00893815

HIV Infections Memory

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

AIDS-Related Dementia Complex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Definite Case

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

Group Type EXPERIMENTAL

Optical Coherence Tomography

Intervention Type OTHER

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

Control

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

Group Type ACTIVE_COMPARATOR

Optical Coherence Tomography

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optical Coherence Tomography

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No