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

NCT02592174 | Completed

• 1 other identifier: ANRS EP58 HAND 55-70
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 6

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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).

  at month 3 (neurocognitive evaluation)

Secondary Outcomes (6)

• The prevalence of Asymptomatic Neurocognitive Impairment (ANI)

  at month 3 (neurocognitive evaluation)

• The prevalence of HIV-Associated Dementia(HAD)

  at month 3 (neurocognitive evaluation)

• The prevalence of Mild Neurocognitive Disorder (MND)

  at month 3 (neurocognitive evaluation)

• Cognitive score distributions untreated or after transformation according to their distribution characteristics

  at month 3 (neurocognitive evaluation)

• Physical score distributions untreated or after transformation according to their distribution characteristics

  at month 3 (neurocognitive evaluation)

Study Arms (1)

HIV subjects

OTHER

* 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.

Other: Health related quality of life and social and demographic informations; Other: Neurocognitive assessment; Radiation: cerebral images sub-study

Interventions

Health related quality of life and social and demographic informations OTHER

At the inclusion visit with a self-assessment questionnaire

HIV subjects

Neurocognitive assessment OTHER

At the neurocognitive visit, with standard test as CONSTANCES cohort

HIV subjects

cerebral images sub-study RADIATION

Standard magnetic resonance imaging

HIV subjects

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An age between 55 and 70 years including,

You may not qualify if:

• free and informed consent,
• Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid is not a Social Security programme)
• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie

Cannes, 06401, France

Location

Hôpital Michallon- Service des Maladies Infectieuses

Grenoble, 38043, France

Location

Hôpial Sainte Marguerite - Service d'hématologie-Cisih

Marseille, 13274, France

Location

Hôpital Gui de Chauliac - Service des Maladies Infectieuses

Montpellier, 34295, France

Location

Hôpital Carémeau - Service des Maladies Infectieuses

Nîmes, 30029, France

Location

Hôpital Bretonneau - Service des Maladies Infectieuses

Tours, 37044, France

Location

Related Publications (1)

• Makinson A, Dubois J, Eymard-Duvernay S, Leclercq P, Zaegel-Faucher O, Bernard L, Vassallo M, Barbuat C, Geny C, Thouvenot E, Costagliola D, Ozguler A, Zins M, Simony M, Reynes J, Berr C. Increased Prevalence of Neurocognitive Impairment in Aging People Living With Human Immunodeficiency Virus: The ANRS EP58 HAND 55-70 Study. Clin Infect Dis. 2020 Jun 10;70(12):2641-2648. doi: 10.1093/cid/ciz670.

  PMID: 31755936 DERIVED

MeSH Terms

Interventions

Quality of Life; Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Claudine Berr

  Inserm U1061

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 30, 2015
• Study Start: January 26, 2016
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

FR (6)