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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
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
October 20, 2015
Last Updated
January 4, 2018
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Merck Sharp & Dohme LLC
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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
No

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
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.
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
No
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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