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

HIV Infections Clinical Trial

— AgingHAND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385588
• Other study ID #: ANRS 0093s Aging HAND
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: Valérie Andriantsoanirina
• Phone: +33 (0) 1 49 59 19 83
• Email: valerie.andriantsoanirina[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• cognitive functional assessment
Self-administered questionnaire Cognitive and functional tests Medical questionnaire Sampling for biobank (28-32 ml will be collected)

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux
France	Hôpital Saint André	Bordeaux
France	CH Cannes	Cannes
France	CHD Vendée	La Roche-sur-Yon
France	CHU Grenoble Alpes	La Tronche
France	Hôpital Sainte Marguerite	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nantes	Nantes
France	Hôpital Carémeau, CHU Nîmes	Nîmes
France	Hopital Pitié Salpêtrière	Paris
France	Hôpital Bretonneau, CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with cognitive decline	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.	12 months
Secondary	Proportion of patients with NCI	Presence of neurocognitive impairment (NCI) according to the Frascati criteria and alternative classifications used to define HIV-Associated Neurocognitive Disorder (HAND) in PLHIV	12 months
Secondary	Description of the causes of NCI confirmed	Description of the causes of NCI confirmed after a consensus reached by an expert panel group	12 months
Secondary	Incidence and prevalence of frailty	The Fried frailty score for the ancillary study on incidence and prevalence of frailty	12 months