<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210130</url>
  </required_header>
  <id_info>
    <org_study_id>AMR_2013-8</org_study_id>
    <nct_id>NCT02210130</nct_id>
  </id_info>
  <brief_title>The Microvascular Brain Retina And Kidney Study</brief_title>
  <acronym>MICROBREAK2</acronym>
  <official_title>Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French National Agency for Research on AIDS and Viral Hepatitis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability&#xD;
      in the general population, secondary to the accumulation of asymptomatic elementary lesions.&#xD;
      CSVD is directly correlated with age and cardiovascular risk factors and therefore would be&#xD;
      challenging in term of public health care in the future. While HIV patients share the same&#xD;
      cardiovascular risk factors and they are often diagnosed with cognitive impairment and&#xD;
      frailty, CSVD has not been yet described in this population.&#xD;
&#xD;
      The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating&#xD;
      the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with&#xD;
      the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular&#xD;
      disease.&#xD;
&#xD;
      HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough&#xD;
      vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the&#xD;
      macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination&#xD;
      and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel&#xD;
      organs. The same number of HIV+/CSVD- matched patients will have the same work-up.&#xD;
&#xD;
      We are expecting to show the relationship between CSVD and cardiovascular risk factors in&#xD;
      order to propose specific prevention. We will correlate the CSVD with the neurologic and&#xD;
      cognitive function as it is already proved in the general population. We will correlate the&#xD;
      CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap&#xD;
      screening tools for the CSVD in the HIV+ population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>determinants of CSCV in patients with HIV</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">163</enrollment>
  <condition>Cerebral Small Vessels Disease</condition>
  <arm_group>
    <arm_group_label>patients HIV+ CSVD+</arm_group_label>
    <description>patients with HIV and cerebral small vessel disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control HIV+ CSVD-</arm_group_label>
    <description>patients with HIV and without cerebral small vessel disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral&#xD;
        (ARV) therapy With (patients) or without Cerebral Small Vessels Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 50 years old&#xD;
&#xD;
          -  chronic HIV seropositive patient infected for at least 5 years&#xD;
&#xD;
          -  antiretroviral therapy&#xD;
&#xD;
          -  plasmatic HIV viral load &lt;40 copies/ml for at least one year with one authorized blip&#xD;
             &lt; 1000 copies/ml per year&#xD;
&#xD;
          -  cerebral small vessels disease (patients) or not (controls)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infection VHC&#xD;
&#xD;
          -  known antecedent of stroke&#xD;
&#xD;
          -  documented neurologic complication of HIV&#xD;
&#xD;
          -  drug user&#xD;
&#xD;
          -  glomerular filtration rate&lt; 15 mL/mn&#xD;
&#xD;
          -  diabetic patient with kidney or retin complications&#xD;
&#xD;
          -  systolic blood pressure≥ 180 and/or diastolic blood pressure≥ 110 mmHg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Small Vessel Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210130
org study id: AMR_2013-8
nct id: NCT02210130
lead sponsor: 
collaborator: 
has dmc: Yes
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 study and describe the CSVD in the HIV+ population by: (1) correlating
      the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with
      the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular
      disease.

      HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough
      vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the
      macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination
      and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel
      organs. The same number of HIV+/CSVD- matched patients will have the same work-up.

      We are expecting to show the relationship between CSVD and cardiovascular risk factors in
      order to propose specific prevention. We will correlate the CSVD with the neurologic and
      cognitive function as it is already proved in the general population. We will correlate the
      CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap
      screening tools for the CSVD in the HIV+ population.
observational model: Case-Control
time perspective: Cross-Sectional
measure: determinants of CSCV in patients with HIV
time frame: baseline
arm group label: patients HIV+ CSVD+
description: patients with HIV and cerebral small vessel disease
arm group label: control HIV+ CSVD-
description: patients with HIV and without cerebral small vessel disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Small Vessel Diseases