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

Not Applicable

Recruiting

• Conditions: HIV Infections
• Interventions: Other: cognitive functional assessment

• Registration Number: NCT05385588
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Study Start: 2022-11-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	cognitive functional assessment	290 PLHIV, aged 55 to 76 years old

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Incidence and prevalence of frailty	12 months	The Fried frailty score for the ancillary study on incidence and prevalence of frailty
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

Trial Locations

Locations (11)

CH Cannes; 🇫🇷 Cannes, France

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Saint André; 🇫🇷 Bordeaux, France

CHU Grenoble Alpes; 🇫🇷 La Tronche, France

Hopital Pitié Salpêtrière; 🇫🇷 Paris, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHU Nantes; 🇫🇷 Nantes, France

Hôpital Sainte Marguerite; 🇫🇷 Marseille, France

CHU Montpellier; 🇫🇷 Montpellier, France

Hôpital Carémeau, CHU Nîmes; 🇫🇷 Nîmes, France

Hôpital Bretonneau, CHU Tours; 🇫🇷 Tours, France