COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65... | NCT03268109

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

NCT03268109

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Jun 25, 2025Actual

Enrollment

281Actual

Phase

Not provided

Conditions

Memory Impairment
HIV/AIDS
Cognitive Impairment

Interventions

assessment of cognitive impairment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2017Actual

Primary Completion Date

May 12, 2025Actual

Completion Date

May 12, 2025Actual

First Submitted Date

Aug 29, 2017

First Submission Date that Met QC Criteria

Aug 29, 2017

First Posted Date

Aug 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

281Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
people living with HIV		subjects infected with HIV and with cognitive complaints	Other: assessment of cognitive impairment
control subjects		subjects not infected with HIV and with cognitive complaints	Other: assessment of cognitive impairment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
assessment of cognitive impairment	Other	Measure of Global Deficit Score	control subjects people living with HIV

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antoine Moulignier, MD	Fondation Ophtalmologique A. de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique A. de Rothschild /URC		Paris		75019	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008569	Memory Disorders
D000163	Acquired Immunodeficiency Syndrome
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided