Skip to main content
OpenTrials
Completed

NCT Number: NCT05385588

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pellegrin, Bordeaux, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive functional assessment

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

Primary outcomes

  1. Proportion of patients with cognitive decline

    Time frame: 12 months

    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 outcomes

  1. Proportion of patients with NCI

    Time frame: 12 months

    Presence of neurocognitive impairment (NCI) according to the Frascati criteria and alternative classifications used to define HIV-Associated Neurocognitive Disorder (HAND) in PLHIV

  2. Description of the causes of NCI confirmed

    Time frame: 12 months

    Description of the causes of NCI confirmed after a consensus reached by an expert panel group

  3. Incidence and prevalence of frailty

    Time frame: 12 months

    The Fried frailty score for the ancillary study on incidence and prevalence of frailty

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Acronym: AgingHAND

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 23, 2022
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.