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MICROBREAK1: Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT02082574
Collaborator
(none)
655
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.

The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.

500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2*).

Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.

We are expecting to prove that CSVD is more frequent in HIV+ population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    655 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1
    Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    HIV infected for more than 5 years, aged over 50, treated with ARV
    control

    non HIV (matched for age and gender)

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral small vessel disease [baseline]

      Cerebral small vessel disease detected with MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age over 50

    • chronic HIV seropositive patient infected for at least 5 years

    • treated with any antiretroviral (ARV) therapy

    • plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year

    Exclusion Criteria:

    • co-infection with hepatitis C virus (HCV)

    • uncontrolled high blood pressure (WHO criteria)

    • Personal history of cerebral infarction or cerebral ischemia

    • Personal history of neurological complication of the HIV-infection

    • Use of illegal drugs (except cannabis or poppers)

    • Glomerular filtration rate < 15 mL/mn

    • Complicated diabetes mellitus (glomerular filtration rate < 60ml/mn and/or proteinuria> 300 mg and/or retinopathy)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondation Ophtalmologique Adolphe de Rothschild Paris Ile de France France 75019

    Sponsors and Collaborators

    • Fondation Ophtalmologique Adolphe de Rothschild

    Investigators

    • Principal Investigator: Antoine MOULIGNIER, Dr, Fondation Ophtalmologique Adolphe de Rothschild

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondation Ophtalmologique Adolphe de Rothschild
    ClinicalTrials.gov Identifier:
    NCT02082574
    Other Study ID Numbers:
    • AMR_2013-6
    First Posted:
    Mar 10, 2014
    Last Update Posted:
    Oct 21, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    HIV Seropositivity
    Cerebral Small Vessel Diseases

    Study Results

    No Results Posted as of Oct 21, 2016