COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old

Completed

• Conditions: Memory Impairment; Cognitive Impairment; HIV/AIDS

• Registration Number: NCT03268109
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Study Start: 2017-09-22
• Primary Completion: 2025-05-12
• Study Completion: 2025-05-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

• Personal or familial cognitive complaints
• Individual aged ≥ 65 years old and < 81 years old
• Instrumental activities of daily living (IADL) score between 3-4
• French speaking individual
• Informed consent signed For PLHIV
• HIV infection
• Undetectable HIV viral load ≥ 1 year
• Current cluster of differentiation (CD4) cell count > 100/mm3 For controls
• negative HIV serology ≤ 6 months

Exclusion Criteria

• Opportunistic infection < 5 years
• Contraindications to MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cognitive impairment	baseline	cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild /URC; 🇫🇷 Paris, France