NCT02592174

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Secondary objectives are: * To study factors associated with Asymptomatic Neurocognitive Impairment (ANI) or Mild Neurocognitive Disorders (MND) by distinguishing the impact of traditional risk factors of neurocognitive impairment and those related to HIV infection, * To compare in the exposed and unexposed population physical characteristics, complaints and comorbidities, * To compare global neurocognitive scores in both populations after standardized normal reduction of each test. 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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
OTHER	Health related quality of life and social and demographic informations	At the inclusion visit with a self-assessment questionnaire
OTHER	Neurocognitive assessment	At the neurocognitive visit, with standard test as CONSTANCES cohort
RADIATION	cerebral images sub-study	Standard magnetic resonance imaging

Timeline

• Start date: 2016-01-26
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2015-10-30
• Last updated: 2018-01-08

Locations

6 sites across 1 country: France