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

HIV-1 Infection Clinical Trial

— HAND55-70  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592174
• Other study ID #: ANRS EP58 HAND 55-70
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: January 4, 2018
• Start date: January 26, 2016
• Est. completion date: October 27, 2017

Study information

• Verified date: January 2018
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1 Infection
• Neurocognitive Disorders

Intervention

Other:
• Health related quality of life and social and demographic informations
At the inclusion visit with a self-assessment questionnaire
• Neurocognitive assessment
At the neurocognitive visit, with standard test as CONSTANCES cohort

Radiation:
• cerebral images sub-study
Standard magnetic resonance imaging

Locations

Country	Name	City	State
France	Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie	Cannes
France	Hôpital Michallon- Service des Maladies Infectieuses	Grenoble
France	Hôpial Sainte Marguerite - Service d'hématologie-Cisih	Marseille
France	Hôpital Gui de Chauliac - Service des Maladies Infectieuses	Montpellier
France	Hôpital Carémeau - Service des Maladies Infectieuses	Nîmes
France	Hôpital Bretonneau - Service des Maladies Infectieuses	Tours

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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).	at month 3 (neurocognitive evaluation)
Secondary	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)
Secondary	Cognitive score distributions untreated or after transformation according to their distribution characteristics		at month 3 (neurocognitive evaluation)
Secondary	Physical score distributions untreated or after transformation according to their distribution characteristics		at month 3 (neurocognitive evaluation)
Secondary	A comparison of a global cognitive score in both populations after standardized normal reduction of each test.		at month 3 (neurocognitive evaluation)