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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; HIV/AIDS; Memory Impairment
• Intervention / Treatment: Other: assessment of cognitive impairment

• Study Type: Observational
• Enrollment (Actual): 281

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique A. de Rothschild /URC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

cART-treated PLHIV ≥65 years old having a memory complaint and virologically controlled for at least 1 year and to compare PLHIV to HIV-uninfected individuals matched for age, sex and educational level

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
people living with HIV; subjects infected with HIV and with cognitive complaints	Other: assessment of cognitive impairment; Measure of Global Deficit Score
control subjects; subjects not infected with HIV and with cognitive complaints	Other: assessment of cognitive impairment; Measure of Global Deficit Score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive impairment	cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Antoine Moulignier, MD, Fondation Ophtalmologique A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AMR_2017_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No