HIV Infections
Conditions
Keywords
HIV, aging, neurocognitive decline, frailty syndromes
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.
Detailed 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
Interventions
OTHERcognitive functional assessment
* Self-administered questionnaire * Cognitive and functional tests * Medical questionnaire * Sampling for biobank (28-32 ml will be collected)
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective study, multicenter
Eligibility
Sex/Gender
ALL
Age
55 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with cognitive decline | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with NCI | 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 |
| Description of the causes of NCI confirmed | 12 months | Description of the causes of NCI confirmed after a consensus reached by an expert panel group |
| Incidence and prevalence of frailty | 12 months | The Fried frailty score for the ancillary study on incidence and prevalence of frailty |
Countries
France
Outcome results
None listed