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

Study Overview
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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.

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

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

Conditions
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HIV Infections

Intervention / Treatment
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* Other: cognitive functional assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective study, multicenter
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>290 PLHIV, aged 55 to 76 years old | Other: cognitive functional assessment<br>* Self-administered questionnaire Cognitive and functional tests Medical questionnaire Sampling for biobank (28-32 ml will be collected)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Description of the causes of NCI confirmed | Description of the causes of NCI confirmed after a consensus reached by an expert panel group | 12 months | 
| Incidence and prevalence of frailty | The Fried frailty score for the ancillary study on incidence and prevalence of frailty | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, aging, neurocognitive decline, frailty syndromes