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HIV-1 InfectionHAND55-70NCT02592174

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

A study testing Health related quality of life and social and demographic informations, Neurocognitive assessment and cerebral images sub-study in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 55 to 70 years
Conditions the study is for
HIV-1 Infection
What is being tested?
Health related quality of life and social and demographic informations, Neurocognitive assessment and cerebral images sub-study
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
6 sitesFrance
Study dates
26 Jan 2016to 27 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie

    Cannes, 06401

  • Hôpital Michallon- Service des Maladies Infectieuses

    Grenoble, 38043

  • Hôpial Sainte Marguerite - Service d'hématologie-Cisih

    Marseille, 13274

  • Hôpital Gui de Chauliac - Service des Maladies Infectieuses

    Montpellier, 34295

  • Hôpital Carémeau - Service des Maladies Infectieuses

    Nîmes, 30029

  • Hôpital Bretonneau - Service des Maladies Infectieuses

    Tours, 37044

Other trials in France

About this 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.

Read the 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
Being tested
Health related quality of life and social and demographic informations, Neurocognitive assessment, cerebral images sub-study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health related quality of life and social and demographic informationsOther

    At the inclusion visit with a self-assessment questionnaire

  • Neurocognitive assessmentOther

    At the neurocognitive visit, with standard test as CONSTANCES cohort

  • cerebral images sub-studyRadiation

    Standard magnetic resonance imaging

Study groups in NCT02592174
Study groupRoleWhat they receive
HIV subjectsOther* 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.
Receives: Other: Health related quality of life and social and demographic informations; Other: Neurocognitive assessment; Radiation: cerebral images sub-study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

    Measured: at month 3 (neurocognitive evaluation)

Secondary outcomes (6)

  1. 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).

    Measured: at month 3 (neurocognitive evaluation)

  2. 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).

    Measured: at month 3 (neurocognitive evaluation)

  3. 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).

    Measured: at month 3 (neurocognitive evaluation)

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

    Measured: at month 3 (neurocognitive evaluation)

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

    Measured: at month 3 (neurocognitive evaluation)

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

    Measured: at month 3 (neurocognitive evaluation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study start26 Jan 2016
  3. Primary completion27 Oct 2017
  4. Study completion27 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592174
Sponsor's protocol ID
ANRS EP58 HAND 55-70
Acronym
HAND55-70
Status last verified
Jan 2018
First submitted
20 Oct 2015
Last updated
8 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31755936

Questions about this trial

What is this clinical trial studying?

A study testing Health related quality of life and social and demographic informations, Neurocognitive assessment and cerebral images sub-study in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02592174, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.

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