COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
- Conditions
- Memory ImpairmentCognitive ImpairmentHIV/AIDS
- Interventions
- Other: assessment of cognitive impairment
- Registration Number
- NCT03268109
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- 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
- Opportunistic infection < 5 years
- Contraindications to MRI
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description people living with HIV assessment of cognitive impairment subjects infected with HIV and with cognitive complaints control subjects assessment of cognitive impairment subjects not infected with HIV and with cognitive complaints
- Primary Outcome Measures
Name Time Method cognitive impairment baseline cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondation Ophtalmologique A. de Rothschild /URC
🇫🇷Paris, France