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 (HAND55-70)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cannes, France, 06401
    • Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie
  • Grenoble, France, 38043
    • Hôpital Michallon- Service des Maladies Infectieuses
  • Marseille, France, 13274
    • Hôpial Sainte Marguerite - Service d'hématologie-Cisih
  • Montpellier, France, 34295
    • Hôpital Gui de Chauliac - Service des Maladies Infectieuses
  • Nîmes, France, 30029
    • Hôpital Carémeau - Service des Maladies Infectieuses
  • Tours, France, 37044
    • Hôpital Bretonneau - Service des Maladies Infectieuses

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For the HIV-infected, inclusion criteria are:

• An age between 55 and 70 years including,
• A HIV-viral load <50 copies/mL for at least 24 months (with a minimum of three viral loads during the 24 months period, and a last viral load within 6 months of inclusion). Blips, defined by a transitory elevation of viral load < 200 copies/ml, are not considered as an exclusion criteria if objectified twice or less during the 24 months period,
• 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)

Non-inclusion criteria are:

• 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.

Inclusion criteria for the subjects from the CONSTANCES cohort are an age between 55 and 70 years. Non-inclusion criteria are the same as the HIV-infected subjects, as well as reported HIV-infection or antiretroviral treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: Health related quality of life and social and demographic informations; At the inclusion visit with a self-assessment questionnaire; Other: Neurocognitive assessment; At the neurocognitive visit, with standard test as CONSTANCES cohort; Radiation: cerebral images sub-study; Standard magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of Asymptomatic Neurocognitive Impairment (ANI)	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)
The prevalence of HIV-Associated Dementia(HAD)	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)
The prevalence of Mild Neurocognitive Disorder (MND)	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)
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)
A comparison of a global cognitive score in both populations after standardized normal reduction of each test.		at month 3 (neurocognitive evaluation)

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Claudine Berr, Inserm U1061

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2016
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: ANRS EP58 HAND 55-70