Clinical Trials Directory

Trials / Completed

CompletedNCT05385588

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
282 (actual)
Sponsor
ANRS, Emerging Infectious Diseases · Other Government
Sex
All
Age
55 Years – 76 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

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

Timeline

Start date
2022-11-14
Primary completion
2024-02-01
Completion
2024-02-01
First posted
2022-05-23
Last updated
2025-01-30

Locations

11 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05385588. Inclusion in this directory is not an endorsement.