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Aging With HIV and Neurocognitive Decline, a Follow-up Study (AgingHAND)

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive functional assessment
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections focused on measuring HIV, aging, neurocognitive decline, frailty syndromes

Eligibility Criteria

55 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Inclusion criteria for PLHIV for the longitudinal study:

  • Having participated in the ANRS EP58 HAND 55-70 study
  • A signed informed consent
  • To be affiliated and benefit from the French Social Security

Inclusion criteria for PLHIV for the transversal study (only for new subjects):

  • HIV-1
  • Aged between 55 years and 76 years;
  • with a viral load < 50 copies/mL for more than 24 months (with a minimum of 3 available viral loads 6 months prior to inclusion). Blips -defined by a transient increase in viral load- are allowed if < 200 copies/mL, with a maximum of two blips within 24 months;
  • With a CD4 (cluster of differentiation 4) count at inclusion ≥ 200 cells/µL for more than the last 12 months (with a last available CD4 count < 6 months of inclusion);
  • A signed informed consent
  • To be affiliated and benefit from the French Social Security

Exclusion criteria

Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies:

  • An Isolated HIV-2 infection
  • Confused or with an ongoing neurological disease
  • Presenting psychiatric syndromes interfering with cognitive evaluation;
  • With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult.
  • With recent extensive neurocognitive evaluation within 6 months prior to inclusion
  • With neurological disease with ongoing clinically relevant sequela
  • Participating in another research program, prohibiting the participating in additional research
  • Vulnerable: minors, under guardianship or curatorship, or persons deprived of liberty for administrative or judiciary reasons

Sites / Locations

  • Hôpital PellegrinRecruiting
  • Hôpital Saint AndréRecruiting
  • CH CannesRecruiting
  • CHD VendéeRecruiting
  • CHU Grenoble AlpesRecruiting
  • Hôpital Sainte MargueriteRecruiting
  • CHU MontpellierRecruiting
  • CHU NantesRecruiting
  • Hôpital Carémeau, CHU NîmesRecruiting
  • Hopital Pitié SalpêtrièreRecruiting
  • Hôpital Bretonneau, CHU ToursRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

290 PLHIV, aged 55 to 76 years old

Outcomes

Primary Outcome Measures

Proportion of patients with cognitive decline
The global cognitive decline of patients, expressed through the mean Z-score (with higher scores indicating better cognition) using the mean of z scores of the 5 following cognitive tests (NPZ 5 score): Trail Making Test A-B (TMT A-B), Digit Symbol Substitution Task (DSST) of the WAIS-IV (Wechsler Adult Intelligence Scale), digital finger tapping test, word fluency and formal lexical and semantic evocation for language, Free and Cued Selective Reminding Test.

Secondary Outcome Measures

Proportion of patients with NCI
Presence of neurocognitive impairment (NCI) according to the Frascati criteria and alternative classifications used to define HIV-Associated Neurocognitive Disorder (HAND) in PLHIV
Description of the causes of NCI confirmed
Description of the causes of NCI confirmed after a consensus reached by an expert panel group
Incidence and prevalence of frailty
The Fried frailty score for the ancillary study on incidence and prevalence of frailty

Full Information

First Posted
May 18, 2022
Last Updated
November 16, 2022
Sponsor
ANRS, Emerging Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05385588
Brief Title
Aging With HIV and Neurocognitive Decline, a Follow-up Study
Acronym
AgingHAND
Official Title
Aging With HIV and Neurocognitive Decline, a Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The ANRS ( Agence Nationale de Recherches sur le Sida et les Hépatites virales) 0093s Aging HAND study is to assess whether PLHIV (People Living with HIV) initially between 55-70 years of age at baseline analysis under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up. Aging HAND is a French, multicentric, longitudinal, transversal, prospective study with inclusion of 290 PLHIV.
Detailed Description
The primary objective of this study is to analyze whether PLHIV initially aged between 55-70 years of age at baseline under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up in comparison with an age, gender and educational level matched HIV non-exposed control group from the CONSTANCES cohort. The secondary objectives of this study are : To determine the prevalence of neurocognitive impairment (NCI) according to the Frascati criteria, clinical consensus and alternative classifications, after additional accrual of individuals aged 55 to 76 years for a more precise and extensive age range analysis of NCI To describe the incidence and prevalence of the frailty syndromes, and their relation with co-morbidities and NCI, using the Fried score as a measure of frailty To constitute a plasma and serum biobank for biomarkers study related to the aging of PLHIV

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, aging, neurocognitive decline, frailty syndromes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective study, multicenter
Masking
None (Open Label)
Allocation
N/A
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
290 PLHIV, aged 55 to 76 years old
Intervention Type
Other
Intervention Name(s)
cognitive functional assessment
Intervention Description
Self-administered questionnaire Cognitive and functional tests Medical questionnaire Sampling for biobank (28-32 ml will be collected)
Primary Outcome Measure Information:
Title
Proportion of patients with cognitive decline
Description
The global cognitive decline of patients, expressed through the mean Z-score (with higher scores indicating better cognition) using the mean of z scores of the 5 following cognitive tests (NPZ 5 score): Trail Making Test A-B (TMT A-B), Digit Symbol Substitution Task (DSST) of the WAIS-IV (Wechsler Adult Intelligence Scale), digital finger tapping test, word fluency and formal lexical and semantic evocation for language, Free and Cued Selective Reminding Test.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of patients with NCI
Description
Presence of neurocognitive impairment (NCI) according to the Frascati criteria and alternative classifications used to define HIV-Associated Neurocognitive Disorder (HAND) in PLHIV
Time Frame
12 months
Title
Description of the causes of NCI confirmed
Description
Description of the causes of NCI confirmed after a consensus reached by an expert panel group
Time Frame
12 months
Title
Incidence and prevalence of frailty
Description
The Fried frailty score for the ancillary study on incidence and prevalence of frailty
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Inclusion criteria for PLHIV for the longitudinal study: Having participated in the ANRS EP58 HAND 55-70 study A signed informed consent To be affiliated and benefit from the French Social Security Inclusion criteria for PLHIV for the transversal study (only for new subjects): HIV-1 Aged between 55 years and 76 years; with a viral load < 50 copies/mL for more than 24 months (with a minimum of 3 available viral loads 6 months prior to inclusion). Blips -defined by a transient increase in viral load- are allowed if < 200 copies/mL, with a maximum of two blips within 24 months; With a CD4 (cluster of differentiation 4) count at inclusion ≥ 200 cells/µL for more than the last 12 months (with a last available CD4 count < 6 months of inclusion); A signed informed consent To be affiliated and benefit from the French Social Security Exclusion criteria Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies: An Isolated HIV-2 infection Confused or with an ongoing neurological disease Presenting psychiatric syndromes interfering with cognitive evaluation; With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult. With recent extensive neurocognitive evaluation within 6 months prior to inclusion With neurological disease with ongoing clinically relevant sequela Participating in another research program, prohibiting the participating in additional research Vulnerable: minors, under guardianship or curatorship, or persons deprived of liberty for administrative or judiciary reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Andriantsoanirina
Phone
+33 (0) 1 49 59 19 83
Email
valerie.andriantsoanirina@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Faroudy Boufassa
Phone
+33 (0) 1 45 21 23 65
Email
faroudy.boufassa@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Makinson
Organizational Affiliation
Department of Infectious and Tropical Diseases, CHU Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pellegrin
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Cazanave
First Name & Middle Initial & Last Name & Degree
Charles Cazanave
Facility Name
Hôpital Saint André
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Bonnet
First Name & Middle Initial & Last Name & Degree
Fabrice Bonnet
Facility Name
CH Cannes
City
Cannes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Vassallo
First Name & Middle Initial & Last Name & Degree
Matteo Vassallo
Facility Name
CHD Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Bollengier-Stragier
First Name & Middle Initial & Last Name & Degree
Olivier Bollengier-Stragier
Facility Name
CHU Grenoble Alpes
City
La Tronche
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Leclercq
First Name & Middle Initial & Last Name & Degree
Pascale Leclercq
Facility Name
Hôpital Sainte Marguerite
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Zaegel
First Name & Middle Initial & Last Name & Degree
Olivia Zaegel
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Makinson
First Name & Middle Initial & Last Name & Degree
Alain Makinson
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde Allavena
First Name & Middle Initial & Last Name & Degree
Clotilde Allavena
Facility Name
Hôpital Carémeau, CHU Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Loubet
First Name & Middle Initial & Last Name & Degree
Paul Loubet
Facility Name
Hopital Pitié Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Palich
First Name & Middle Initial & Last Name & Degree
Romain Palich
Facility Name
Hôpital Bretonneau, CHU Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien Lemaignen
First Name & Middle Initial & Last Name & Degree
Adrien Lemaignen

12. IPD Sharing Statement

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Aging With HIV and Neurocognitive Decline, a Follow-up Study

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