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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie, Cannes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health related quality of life and social and demographic informations

Other

At the inclusion visit with a self-assessment questionnaire

Neurocognitive Assessment

Other

At the neurocognitive visit, with standard test as CONSTANCES cohort

cerebral images sub-study

Radiation

Standard magnetic resonance imaging

Primary outcomes

  1. 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.

    Time frame: at month 3 (neurocognitive evaluation)

    Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).

Secondary outcomes

  1. The prevalence of Asymptomatic Neurocognitive Impairment (ANI)

    Time frame: at month 3 (neurocognitive evaluation)

    Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).

  2. The prevalence of HIV-Associated Dementia(HAD)

    Time frame: at month 3 (neurocognitive evaluation)

    Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).

  3. The prevalence of Mild Neurocognitive Disorder (MND)

    Time frame: at month 3 (neurocognitive evaluation)

    Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).

  4. Cognitive score distributions untreated or after transformation according to their distribution characteristics

    Time frame: at month 3 (neurocognitive evaluation)

  5. Physical score distributions untreated or after transformation according to their distribution characteristics

    Time frame: at month 3 (neurocognitive evaluation)

  6. A comparison of a global cognitive score in both populations after standardized normal reduction of each test.

    Time frame: at month 3 (neurocognitive evaluation)

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: HAND55-70

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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