<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/NCT03298360</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS EP63 RESTA 32a</org_study_id>
    <nct_id>NCT03298360</nct_id>
  </id_info>
  <brief_title>A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a</brief_title>
  <acronym>ANRS EP63</acronym>
  <official_title>A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients&#xD;
      who have participated in the ANRS 139 TRIO trial, always followed and in virological success,&#xD;
      and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to&#xD;
      reconstruct the chronology of the installation of this reservoir.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives&#xD;
&#xD;
      Principal objective&#xD;
&#xD;
      To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients&#xD;
      who have participated in the ANRS 139 TRIO trial, always followed and in virological success,&#xD;
      and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to&#xD;
      reconstruct the chronology of the installation of this reservoir.&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
      To analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV&#xD;
      reservoir markers, currently being identified, in these same patients&#xD;
&#xD;
      Methodology&#xD;
&#xD;
      Pathophysiological study, in patients infected by multi drug-resistant viruses&#xD;
&#xD;
      Estimated enrollment&#xD;
&#xD;
      21 participants (total and per group)&#xD;
&#xD;
      Intervention&#xD;
&#xD;
      167mL blood sample in EDTA tube:&#xD;
&#xD;
        -  160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)&#xD;
&#xD;
        -  7mL (1tube of 7mL): to measure HIV-RNA in centers&#xD;
&#xD;
      Estimated planning or Study / Trial timetable&#xD;
&#xD;
      Study start date: September 2017&#xD;
&#xD;
      Enrollment period: 12 months&#xD;
&#xD;
      Total study duration: 24 months (analyses included)&#xD;
&#xD;
      Estimated study/trial completion date: September 2019 (one year after enrollment of the last&#xD;
      patient)&#xD;
&#xD;
      Study design&#xD;
&#xD;
      Cross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit,&#xD;
      after signature of written informed consent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients</measure>
    <time_frame>inclusion</time_frame>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>HIV Infections</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HIV Infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who participated to ANRS139 TRIO trial, and still followed in centers&#xD;
&#xD;
          -  Who remained in virological success since the participation at the trial: 90% of HIV-1&#xD;
             RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are&#xD;
             tolerated&#xD;
&#xD;
          -  Genotypic resistance profiles available at baseline and before trial&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Affiliate or beneficiary of a social security system (the State Medical Aid or AME is&#xD;
             not a social security system).&#xD;
&#xD;
          -  Written informed consent signed by the person and the investigator before any exam&#xD;
             performed in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial&#xD;
&#xD;
          -  Patient participating in another research evaluating other treatments with an&#xD;
             exclusion period ongoing at the screening visit.&#xD;
&#xD;
          -  Person under legal guardianship or deprived of liberty by a judicial or administrative&#xD;
             decision.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Monsef BENKIRANE</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV cell reservoir</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</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/NCT03298360
org study id: ANRS EP63 RESTA 32a
nct id: NCT03298360
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients
      who have participated in the ANRS 139 TRIO trial, always followed and in virological success,
      and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to
      reconstruct the chronology of the installation of this reservoir.
Objectives

      Principal objective

      To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients
      who have participated in the ANRS 139 TRIO trial, always followed and in virological success,
      and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to
      reconstruct the chronology of the installation of this reservoir.

      Secondary objectives

      To analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV
      reservoir markers, currently being identified, in these same patients

      Methodology

      Pathophysiological study, in patients infected by multi drug-resistant viruses

      Estimated enrollment

      21 participants (total and per group)

      Intervention

      167mL blood sample in EDTA tube:

        -  160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)

        -  7mL (1tube of 7mL): to measure HIV-RNA in centers

      Estimated planning or Study / Trial timetable

      Study start date: September 2017

      Enrollment period: 12 months

      Total study duration: 24 months (analyses included)

      Estimated study/trial completion date: September 2019 (one year after enrollment of the last
      patient)

      Study design

      Cross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit,
      after signature of written informed consent
observational model: Other
time perspective: Other
measure: Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients
time frame: inclusion
intervention type: Other
intervention name: Blood sample
description: 167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: HIV Infections