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

A

ANRS, Emerging Infectious Diseases

Status

Enrolling

Conditions

HIV Infections

Treatments

Other: cognitive functional assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT05385588
ANRS 0093s Aging HAND

Details and patient eligibility

About

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.

Full 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

Enrollment

290 estimated patients

Sex

All

Ages

55 to 76 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

290 participants in 1 patient group

Single arm
Experimental group
Description:
290 PLHIV, aged 55 to 76 years old
Treatment:
Other: cognitive functional assessment

Trial contacts and locations

0

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Central trial contact

Faroudy Boufassa; Valérie Andriantsoanirina

Data sourced from clinicaltrials.gov

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