Clinical trial NCT05385588: Aging With HIV and Neurocognitive Decline, a Follow-up Study
Official title: Aging With HIV and Neurocognitive Decline, a Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
aging
neurocognitive decline
frailty syndromes
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2022-05-23
Enrollment: 282
Sex: ALL
Minimum age (years): 55
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective study, multicenter
Primary purpose: OTHER

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

Eligibility 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

Primary outcomes:
measure: Proportion of patients with cognitive decline
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with NCI
timeFrame: 12 months
measure: Description of the causes of NCI confirmed
timeFrame: 12 months
measure: Incidence and prevalence of frailty
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Cannes
country: France
facility: CH Cannes
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Marseille
country: France
facility: Hôpital Sainte Marguerite
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Nîmes
country: France
facility: Hôpital Carémeau, CHU Nîmes
city: Paris
country: France
facility: Hopital Pitié Salpêtrière
city: Tours
country: France
facility: Hôpital Bretonneau, CHU Tours
Study officials:
affiliation: Department of Infectious and Tropical Diseases, CHU Montpellier
name: Alain Makinson
role: PRINCIPAL_INVESTIGATOR
References: