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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)

Primary Purpose

HIV-1 Infection

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Health related quality of life and social and demographic informations

Neurocognitive assessment

cerebral images sub-study

About this trial

This is an interventional diagnostic trial for HIV-1 Infection

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie
Hôpital Michallon- Service des Maladies Infectieuses
Hôpial Sainte Marguerite - Service d'hématologie-Cisih
Hôpital Gui de Chauliac - Service des Maladies Infectieuses
Hôpital Carémeau - Service des Maladies Infectieuses
Hôpital Bretonneau - Service des Maladies Infectieuses

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HIV subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

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

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

A comparison of a global cognitive score in both populations after standardized normal reduction of each test.

Full Information

NCT ID

NCT02592174

First Posted

October 20, 2015

Last Updated

January 4, 2018

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02592174

Brief Title

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

Acronym

HAND55-70

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 26, 2016 (Actual)

Primary Completion Date

October 27, 2017 (Actual)

Study Completion Date

October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1 Infection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIV subjects

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Health related quality of life and social and demographic informations

Intervention Description

At the inclusion visit with a self-assessment questionnaire

Intervention Type

Other

Intervention Name(s)

Neurocognitive assessment

Intervention Description

At the neurocognitive visit, with standard test as CONSTANCES cohort

Intervention Type

Radiation

Intervention Name(s)

cerebral images sub-study

Intervention Description

Standard magnetic resonance imaging

Primary Outcome Measure Information:

Title

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.

Description

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

Time Frame

at month 3 (neurocognitive evaluation)

Secondary Outcome Measure Information:

Title

The prevalence of Asymptomatic Neurocognitive Impairment (ANI)

Description

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

Time Frame

at month 3 (neurocognitive evaluation)

Title

The prevalence of HIV-Associated Dementia(HAD)

Description

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

Time Frame

at month 3 (neurocognitive evaluation)

Title

The prevalence of Mild Neurocognitive Disorder (MND)

Description

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

Time Frame

at month 3 (neurocognitive evaluation)

Title

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

Time Frame

at month 3 (neurocognitive evaluation)

Title

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

Time Frame

at month 3 (neurocognitive evaluation)

Title

A comparison of a global cognitive score in both populations after standardized normal reduction of each test.

Time Frame

at month 3 (neurocognitive evaluation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudine Berr

Organizational Affiliation

Inserm U1061

Official's Role

Study Director

Facility Information:

Facility Name

Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie

City

Cannes

ZIP/Postal Code

06401

Country

France

Facility Name

Hôpital Michallon- Service des Maladies Infectieuses

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Hôpial Sainte Marguerite - Service d'hématologie-Cisih

City

Marseille

ZIP/Postal Code

13274

Country

France

Facility Name

Hôpital Gui de Chauliac - Service des Maladies Infectieuses

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hôpital Carémeau - Service des Maladies Infectieuses

City

Nîmes

ZIP/Postal Code

30029

Country

France

Facility Name

Hôpital Bretonneau - Service des Maladies Infectieuses

City

Tours

ZIP/Postal Code

37044

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

31755936

Citation

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.

Results Reference

derived

Learn more about this trial

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

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