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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT03268109

Collaborator

(none)

330

Enrollment

Location

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Memory Impairment HIV/AIDS Cognitive Impairment	Other: assessment of cognitive impairment

Study Design

Study Type:

Observational

Anticipated Enrollment :

330 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 22, 2017

Anticipated Primary Completion Date :

Feb 22, 2023

Anticipated Study Completion Date :

Sep 22, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

cognitive impairment [baseline]
cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique A. de Rothschild /URC	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: Antoine Moulignier, MD, Fondation Ophtalmologique A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT03268109

Other Study ID Numbers:

AMR_2017_3

First Posted:

Aug 31, 2017

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Apr 14, 2022