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

NCT03268109 | Completed

• 1 other identifier: AMR_2017_3
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Impairment; HIV/AIDS; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• cognitive impairment

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

  baseline

Study Arms (2)

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

assessment of cognitive impairment OTHER

Measure of Global Deficit Score

control subjects; people living with HIV

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Opportunistic infection \< 5 years
• Contraindications to MRI

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild /URC

Paris, 75019, France

Location

MeSH Terms

Conditions

Memory Disorders; Acquired Immunodeficiency Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Antoine Moulignier, MD

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: September 22, 2017
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FR (1)