Prevalence, Characteristics and Risk Factors of HIV-Associated Neurocognitive Disorders in Subjects Between the Ages of 55 and 70 Years: An Exposed/Unexposed Cross Sectional Study (HAND55-70)
HIV-1 Infection
About this trial
This is an interventional diagnostic trial for HIV-1 Infection
Eligibility Criteria
For the HIV-infected, inclusion criteria are:
- An age between 55 and 70 years including,
- A HIV-viral load <50 copies/mL for at least 24 months (with a minimum of three viral loads during the 24 months period, and a last viral load within 6 months of inclusion). Blips, defined by a transitory elevation of viral load < 200 copies/ml, are not considered as an exclusion criteria if objectified twice or less during the 24 months period,
- A CD4 cells level ≥ 200 cells/µL during the 12 months preceding inclusion, with a last CD4 cells value < 6 months from inclusion,
- free and informed consent,
- Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid is not a Social Security programme)
Non-inclusion criteria are:
- Delirium or active central nervous system disease
- Major psychiatric disease, sensory loss, illiteracy, language barrier inducing difficulties in neurocognitive assessment,
- Neurocognitive extensive evaluation in the last 6 months,
- History of neurological disease with clinical sequels,
- Subjects participating in a study excluding participating in another study,
- Vulnerability, such as an age under 18, tutorship, guardianship, or subjects deprived of liberty by a legal or administrative decision.
Inclusion criteria for the subjects from the CONSTANCES cohort are an age between 55 and 70 years. Non-inclusion criteria are the same as the HIV-infected subjects, as well as reported HIV-infection or antiretroviral treatment.
Sites / Locations
- Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie
- Hôpital Michallon- Service des Maladies Infectieuses
- Hôpial Sainte Marguerite - Service d'hématologie-Cisih
- Hôpital Gui de Chauliac - Service des Maladies Infectieuses
- Hôpital Carémeau - Service des Maladies Infectieuses
- Hôpital Bretonneau - Service des Maladies Infectieuses
Arms of the Study
Arm 1
Other
HIV subjects
Evaluation of health-related quality of life and collection of social and demographic informations at the inclusion visit. Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at the neurocognitive visit. Two substudies will be proposed: cerebral images sub-study (80 patients in the centers of Montpellier and the centers of Nîmes) sub-study on immune activating markers with sample's collection (plasma), 85 patients in the centers of Montpellier and the centers of Nîmes.