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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective study, multicenter

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single arm

290 PLHIV, aged 55 to 76 years old

Group Type EXPERIMENTAL

cognitive functional assessment

Intervention Type OTHER

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

Interventions

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cognitive functional assessment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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;
* 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

* 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No