NCT05385588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

May 18, 2022

Last Update Submit

January 29, 2025

Conditions

HIV Infections

Keywords

HIVagingneurocognitive declinefrailty syndromes

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (3)

  • Proportion of patients with NCI

    12 months

  • Description of the causes of NCI confirmed

    12 months

  • Incidence and prevalence of frailty

    12 months

Study Arms (1)

Single arm

EXPERIMENTAL

290 PLHIV, aged 55 to 76 years old

Other: cognitive functional assessment

Interventions

cognitive functional assessmentOTHER

* Self-administered questionnaire * Cognitive and functional tests * Medical questionnaire * Sampling for biobank (28-32 ml will be collected)

Single arm

Eligibility Criteria

Age55 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having participated in the ANRS EP58 HAND 55-70 study
  • A signed informed consent
  • To be affiliated and benefit from the French Social Security
  • HIV-1
  • Aged between 55 years and 76 years;
  • A signed informed consent
  • To be affiliated and benefit from the French Social Security

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Pellegrin

Bordeaux, France

Location

Hôpital Saint André

Bordeaux, France

Location

CH Cannes

Cannes, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

CHU Grenoble Alpes

La Tronche, France

Location

Hôpital Sainte Marguerite

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nantes

Nantes, France

Location

Hôpital Carémeau, CHU Nîmes

Nîmes, France

Location

Hopital Pitié Salpêtrière

Paris, France

Location

Hôpital Bretonneau, CHU Tours

Tours, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Alain Makinson

    Department of Infectious and Tropical Diseases, CHU Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective study, multicenter
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

November 14, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations

FR(11)