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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV subjects | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health related quality of life and social and demographic informations | Other | At the inclusion visit with a self-assessment questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at month 3 (neurocognitive evaluation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at month 3 (neurocognitive evaluation) |
| The prevalence of HIV-Associated Dementia(HAD) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Claudine Berr | Inserm U1061 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie | Cannes | 06401 | France | |||
| Hôpital Michallon- Service des Maladies Infectieuses |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31755936 | Derived | Makinson A, Dubois J, Eymard-Duvernay S, Leclercq P, Zaegel-Faucher O, Bernard L, Vassallo M, Barbuat C, Geny C, Thouvenot E, Costagliola D, Ozguler A, Zins M, Simony M, Reynes J, Berr C. Increased Prevalence of Neurocognitive Impairment in Aging People Living With Human Immunodeficiency Virus: The ANRS EP58 HAND 55-70 Study. Clin Infect Dis. 2020 Jun 10;70(12):2641-2648. doi: 10.1093/cid/ciz670. |
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| Neurocognitive assessment | Other | At the neurocognitive visit, with standard test as CONSTANCES cohort |
|
| cerebral images sub-study | Radiation | Standard magnetic resonance imaging |
|
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit). |
| 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). | at month 3 (neurocognitive evaluation) |
| Cognitive score distributions untreated or after transformation according to their distribution characteristics | at month 3 (neurocognitive evaluation) |
| Physical score distributions untreated or after transformation according to their distribution characteristics | at month 3 (neurocognitive evaluation) |
| A comparison of a global cognitive score in both populations after standardized normal reduction of each test. | at month 3 (neurocognitive evaluation) |
| Grenoble |
| 38043 |
| France |
| Hôpial Sainte Marguerite - Service d'hématologie-Cisih | Marseille | 13274 | France |
| Hôpital Gui de Chauliac - Service des Maladies Infectieuses | Montpellier | 34295 | France |
| Hôpital Carémeau - Service des Maladies Infectieuses | Nîmes | 30029 | France |
| Hôpital Bretonneau - Service des Maladies Infectieuses | Tours | 37044 | France |
| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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