Prevalence, Characteristics and Risk Factors of HIV-Associated Neurocognitive Disorders in Subjects Between the Ages of 55 and 70 Years: An Exposed/Unexposed Cross Sectional Study

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-26

Study Completion Date

2017-10-27

Brief Summary

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The primary objective is to measure the prevalence of according to the Frascati classification in a HIV-infected population aged between 55 and 70 years (exposed group) and to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on age, gender, geographical origin and socioprofessional category.

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Detailed Description

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Secondary objectives are:

* To study factors associated with Asymptomatic Neurocognitive Impairment (ANI) or Mild Neurocognitive Disorders (MND) by distinguishing the impact of traditional risk factors of neurocognitive impairment and those related to HIV infection,
* To compare in the exposed and unexposed population physical characteristics, complaints and comorbidities,
* To compare global neurocognitive scores in both populations after standardized normal reduction of each test.

Methodology:

HIV-infected subjects aged between 55 and 70 years will be recruited in centres that support people who living with HIV usually. The study will be proposed consecutively to all subjects aged between 55 and 70 year. A brief inquiry will collect motives on subjects that refuse to participate. A minimum of 70 subjects by 5 years age categories will be included. Unexposed subjects will be recruited in the same regions as their HIV-infected counterparts from the CONSTANCES database, a general population health cohort, after random selection matched on age, gender, geographical origin and socioprofessional category (2 HIV-unexposed subjects for 1 exposed subject). Data collection will follow the same methods as in the CONSTANCES cohort, in particular the neurocognitive tests by trained neuropsychologists.

Conditions

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HIV-1 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HIV subjects

* Evaluation of health-related quality of life and collection of social and demographic informations at the inclusion visit.
* Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at the neurocognitive visit.
* Two substudies will be proposed:

* cerebral images sub-study (80 patients in the centers of Montpellier and the centers of Nîmes)
* sub-study on immune activating markers with sample's collection (plasma), 85 patients in the centers of Montpellier and the centers of Nîmes.

Group Type OTHER

Health related quality of life and social and demographic informations

Intervention Type OTHER

At the inclusion visit with a self-assessment questionnaire

Neurocognitive assessment

Intervention Type OTHER

At the neurocognitive visit, with standard test as CONSTANCES cohort

cerebral images sub-study

Intervention Type RADIATION

Standard magnetic resonance imaging

Interventions

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Health related quality of life and social and demographic informations

At the inclusion visit with a self-assessment questionnaire

Intervention Type OTHER

Neurocognitive assessment

At the neurocognitive visit, with standard test as CONSTANCES cohort

Intervention Type OTHER

cerebral images sub-study

Standard magnetic resonance imaging

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* An age between 55 and 70 years including,

* Delirium or active central nervous system disease
* Major psychiatric disease, sensory loss, illiteracy, language barrier inducing difficulties in neurocognitive assessment,
* Neurocognitive extensive evaluation in the last 6 months,
* History of neurological disease with clinical sequels,
* Subjects participating in a study excluding participating in another study,
* Vulnerability, such as an age under 18, tutorship, guardianship, or subjects deprived of liberty by a legal or administrative decision.

Exclusion Criteria

* A CD4 cells level ≥ 200 cells/µL during the 12 months preceding inclusion, with a last CD4 cells value \< 6 months from inclusion,
* free and informed consent,
* Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid is not a Social Security programme)

Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No