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

Not Applicable

Completed

• Conditions: HIV-1 Infection
• Interventions: Other: Health related quality of life and social and demographic informations; Other: Neurocognitive assessment; Radiation: cerebral images sub-study

• Registration Number: NCT02592174
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Study Start: 2016-01-26
• Primary Completion: 2017-10-27
• Study Completion: 2017-10-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV subjects	Health related quality of life and social and demographic informations	* 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.
HIV subjects	Neurocognitive assessment	* 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.
HIV subjects	cerebral images sub-study	* 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.

Primary Outcome Measures

Name	Time	Method
The Prevalence of Neurocognitive troubles HAND in the HIV-infected and to compare it with the prevalence in the HIV-unexposed population in the CONSTANCES cohort.	at month 3 (neurocognitive evaluation)	Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).

Secondary Outcome Measures

Name	Time	Method
Cognitive score distributions untreated or after transformation according to their distribution characteristics	at month 3 (neurocognitive evaluation)
A comparison of a global cognitive score in both populations after standardized normal reduction of each test.	at month 3 (neurocognitive evaluation)
The prevalence of Asymptomatic Neurocognitive Impairment (ANI)	at month 3 (neurocognitive evaluation)	Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
The prevalence of Mild Neurocognitive Disorder (MND)	at month 3 (neurocognitive evaluation)	Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
The prevalence of HIV-Associated Dementia(HAD)	at month 3 (neurocognitive evaluation)	Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
Physical score distributions untreated or after transformation according to their distribution characteristics	at month 3 (neurocognitive evaluation)

Trial Locations

Locations (6)

Hôpital Michallon- Service des Maladies Infectieuses; 🇫🇷 Grenoble, France

Hôpital Bretonneau - Service des Maladies Infectieuses; 🇫🇷 Tours, France

Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie; 🇫🇷 Cannes, France

Hôpital Gui de Chauliac - Service des Maladies Infectieuses; 🇫🇷 Montpellier, France

Hôpial Sainte Marguerite - Service d'hématologie-Cisih; 🇫🇷 Marseille, France

Hôpital Carémeau - Service des Maladies Infectieuses; 🇫🇷 Nîmes, France