Assessing cognitive impairment in older HIV-infected patients
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.
This study is trying to see how common memory and thinking problems are in older adults with HIV who are on treatment, to help find ways to support them better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Drugs / interventions | cART |
| Locations | 1 site (Paris) |
| Trial ID | NCT03268109 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify the frequency of HIV-associated neurocognitive disorders (HAND) in individuals aged 65 years and older living with HIV. It focuses on patients who have been on combined antiretroviral therapy (cART) and are at risk for cognitive impairment due to aging. Participants will undergo assessments to evaluate their cognitive function, which is crucial for planning early interventions to mitigate disabilities related to memory impairment. The study will include both HIV-infected individuals and control participants with negative HIV serology.
Who should consider this trial
Good fit: Ideal candidates are French-speaking individuals aged 65 to 80 years with HIV who have been stable on treatment and have cognitive complaints.
Not a fit: Patients with recent opportunistic infections or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early interventions for cognitive impairment in older adults living with HIV.
How similar studies have performed: Other studies have indicated that cognitive impairment is a significant issue in older HIV-infected populations, suggesting that this approach is relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Fondation Ophtalmologique A. de Rothschild /URC — Paris, France (Recruiting)
Study contacts
- Principal investigator: Antoine Moulignier, MD — Fondation Ophtalmologique A. de Rothschild
- Study coordinator: Amélie Yavchitz, MD, PhD
- Email: ayavchitz@for.paris
- Phone: 0033148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.