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

NCT ID: NCT03268109

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-22

Study Completion Date

2025-05-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Memory Impairment HIV/AIDS Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

people living with HIV

subjects infected with HIV and with cognitive complaints

assessment of cognitive impairment

Intervention Type OTHER

Measure of Global Deficit Score

control subjects

subjects not infected with HIV and with cognitive complaints

assessment of cognitive impairment

Intervention Type OTHER

Measure of Global Deficit Score

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

assessment of cognitive impairment

Measure of Global Deficit Score

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine Moulignier, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondation Ophtalmologique A. de Rothschild /URC

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMR_2017_3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Executive Functioning Training Study
NCT05598047 COMPLETED PHASE2