An interventional study of Health related quality of life and social and demographic informations and Neurocognitive assessment in HIV-1 Infection, sponsored by ANRS, Emerging Infectious Diseases. Completed at 6 sites in France. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by ANRS, Emerging Infectious Diseases · Not applicable, Interventional, and Diagnostic
The primary objective is to measure the prevalence of according to the Frascati classification in a HIV-infected population aged between 55 and 70 years (exposed group) and to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on age, gender, geographical origin and socioprofessional category.
Secondary objectives are:
Methodology:
HIV-infected subjects aged between 55 and 70 years will be recruited in centres that support people who living with HIV usually. The study will be proposed consecutively to all subjects aged between 55 and 70 year. A brief inquiry will collect motives on subjects that refuse to participate. A minimum of 70 subjects by 5 years age categories will be included. Unexposed subjects will be recruited in the same regions as their HIV-infected counterparts from the CONSTANCES database, a general population health cohort, after random selection matched on age, gender, geographical origin and socioprofessional category (2 HIV-unexposed subjects for 1 exposed subject). Data collection will follow the same methods as in the CONSTANCES cohort, in particular the neurocognitive tests by trained neuropsychologists.
246 studies on the registry are indexed under Neurocognitive Disorders; 88 are open to participants now.
This study's enrollment of 220 is above the median of 72 across 150 interventional studies indexed under Neurocognitive Disorders.
Browse Neurocognitive Disorders studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the HIV-infected, inclusion criteria are:
Non-inclusion criteria are:
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.
* 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.
Other: Health related quality of life and social and demographic informations · Other: Neurocognitive assessment · Radiation: cerebral images sub-study
At the inclusion visit with a self-assessment questionnaire
At the neurocognitive visit, with standard test as CONSTANCES cohort
Standard magnetic resonance imaging
The Prevalence of Neurocognitive troubles HAND in the HIV-infected and to compare it with the prevalence in the HIV-unexposed population in the CONSTANCES cohort.
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
Time frame: at month 3 (neurocognitive evaluation)
The prevalence of Asymptomatic Neurocognitive Impairment (ANI)
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
Time frame: at month 3 (neurocognitive evaluation)
The prevalence of HIV-Associated Dementia(HAD)
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
Time frame: at month 3 (neurocognitive evaluation)
The prevalence of Mild Neurocognitive Disorder (MND)
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
Time frame: at month 3 (neurocognitive evaluation)
Cognitive score distributions untreated or after transformation according to their distribution characteristics
Time frame: at month 3 (neurocognitive evaluation)
Physical score distributions untreated or after transformation according to their distribution characteristics
Time frame: at month 3 (neurocognitive evaluation)
A comparison of a global cognitive score in both populations after standardized normal reduction of each test.
Time frame: at month 3 (neurocognitive evaluation)
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ANRS, Emerging Infectious Diseases