<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/NCT03268109</url>
  </required_header>
  <id_info>
    <org_study_id>AMR_2017_3</org_study_id>
    <nct_id>NCT03268109</nct_id>
  </id_info>
  <brief_title>COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old</brief_title>
  <acronym>COGITO</acronym>
  <official_title>COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive&#xD;
      disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at&#xD;
      risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to&#xD;
      quantify for planning early intervention to attenuate both functional and occupational&#xD;
      disabilities due to cognitive impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Anticipated">September 22, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 22, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive impairment</measure>
    <time_frame>baseline</time_frame>
    <description>cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Memory Impairment</condition>
  <condition>HIV/AIDS</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>people living with HIV</arm_group_label>
    <description>subjects infected with HIV and with cognitive complaints</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control subjects</arm_group_label>
    <description>subjects not infected with HIV and with cognitive complaints</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>assessment of cognitive impairment</intervention_name>
    <description>Measure of Global Deficit Score</description>
    <arm_group_label>control subjects</arm_group_label>
    <arm_group_label>people living with HIV</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        cART-treated PLHIV ≥65 years old having a memory complaint and virologically controlled for&#xD;
        at least 1 year and to compare PLHIV to HIV-uninfected individuals matched for age, sex and&#xD;
        educational level&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Personal or familial cognitive complaints&#xD;
&#xD;
          -  Individual aged ≥ 65 years old and &lt; 81 years old&#xD;
&#xD;
          -  Instrumental activities of daily living (IADL) score between 3-4&#xD;
&#xD;
          -  French speaking individual&#xD;
&#xD;
          -  Informed consent signed For PLHIV&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Undetectable HIV viral load ≥ 1 year&#xD;
&#xD;
          -  Current cluster of differentiation (CD4) cell count &gt; 100/mm3 For controls&#xD;
&#xD;
          -  negative HIV serology ≤ 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opportunistic infection &lt; 5 years&#xD;
&#xD;
          -  Contraindications to MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine Moulignier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ophtalmologique A. de Rothschild</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amélie Yavchitz, MD, PhD</last_name>
    <phone>0033148036454</phone>
    <email>ayavchitz@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucia Lopes</last_name>
    <email>llopes@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild /URC</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fondation Ophtalmologique A. de R /URC</last_name>
      <phone>148036433</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>February 11, 2023</last_update_submitted>
  <last_update_submitted_qc>February 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</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>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03268109
org study id: AMR_2017_3
nct id: NCT03268109
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive
      disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at
      risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to
      quantify for planning early intervention to attenuate both functional and occupational
      disabilities due to cognitive impairment.
observational model: Other
time perspective: Cross-Sectional
measure: cognitive impairment
time frame: baseline
description: cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains
arm group label: people living with HIV
description: subjects infected with HIV and with cognitive complaints
arm group label: control subjects
description: subjects not infected with HIV and with cognitive complaints
intervention type: Other
intervention name: assessment of cognitive impairment
description: Measure of Global Deficit Score
arm group label: control subjects
arm group label: people living with HIV
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine Moulignier, MD
role: Principal Investigator
affiliation: Fondation Ophtalmologique A. de Rothschild
last name: Amélie Yavchitz, MD, PhD
phone: 0033148036454
email: ayavchitz@for.paris
last name: Lucia Lopes
email: llopes@for.paris
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: Undecided