Status:
COMPLETED
Aging With HIV and Neurocognitive Decline, a Follow-up Study
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
HIV Infections
Eligibility:
All Genders
55-76 years
Phase:
NA
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 basel...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT05385588
Start Date
November 14 2022
End Date
February 1 2024
Last Update
January 30 2025
Active Locations (11)
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1
Hôpital Pellegrin
Bordeaux, France
2
Hôpital Saint André
Bordeaux, France
3
CH Cannes
Cannes, France
4
CHD Vendée
La Roche-sur-Yon, France