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
| Type | Name | Description |
|---|---|---|
| OTHER | cognitive 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.