<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/NCT01687452</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A00015-36</org_study_id>
    <secondary_id>2010-25</secondary_id>
    <nct_id>NCT01687452</nct_id>
  </id_info>
  <brief_title>Microparticles, Vector of Genetic Information During HIV Infection</brief_title>
  <official_title>Microparticles, Vector of Genetic Information During HIV Infection ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the investigators study is to demonstrate in healthy subjects and a cohort of&#xD;
      patients infected with HIV, the presence of miRNAs in circulating peripheral blood&#xD;
      microparticles (MPs).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NUMBER OF miRNAs</measure>
    <time_frame>2 YEARS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstrate the presence of miRNAs in microparticles</measure>
    <time_frame>2 YEARS</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>HIV,</condition>
  <arm_group>
    <arm_group_label>Groupe A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load &gt; 1000 copies / ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load &gt; 40 copies / ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <arm_group_label>Groupe A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 40 +/-10 years&#xD;
&#xD;
          -  Seronegativity for the HIV 2&#xD;
&#xD;
          -  Patients of the group A: seropositivity for the HIV 1 confirmed in ELISA and Western&#xD;
             Blot for at least 2 years and having never received from antiretroviral treatment,&#xD;
             with a viral plasmatique load &gt; 1000 copies / ml&#xD;
&#xD;
          -  Patients of the group B: seropositivity for the HIV 1 confirmed in ELISA and Western&#xD;
             Blot for at least 2 years and under stable antiretroviral treatment for at least 6&#xD;
             months, with a viral load undetectable plasmatique (&lt; 40 copies / ml)&#xD;
&#xD;
          -  patients of the group C : Matching on the age (+/-3 years) to a patient&#xD;
&#xD;
          -  Be considered healthy by the Investigator after a clinical examination Seronegativity&#xD;
             for the HIV 1 confirmed in ELISA the day of the taking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        group A et B&#xD;
&#xD;
          -  Age of &lt; 30 years and &gt; in 50 years&#xD;
&#xD;
          -  Seropositivity for the HIV 2&#xD;
&#xD;
        group C Seropositivity for the HIV 2&#xD;
&#xD;
        - Be under medicinal treatment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 31, 2011</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</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>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/NCT01687452
org study id: 2011-A00015-36
secondary id: 2010-25
nct id: NCT01687452
lead sponsor: 
has dmc: No
The aim of the investigators study is to demonstrate in healthy subjects and a cohort of
      patients infected with HIV, the presence of miRNAs in circulating peripheral blood
      microparticles (MPs).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: NUMBER OF miRNAs
time frame: 2 YEARS
measure: Demonstrate the presence of miRNAs in microparticles
time frame: 2 YEARS
arm group label: Groupe A
arm group type: Experimental
description: Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml
arm group label: group B
arm group type: Experimental
description: Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml
arm group label: group C
arm group type: Placebo Comparator
description: Healthy volunteers
intervention type: Biological
intervention name: Blood samples
arm group label: Groupe A
arm group label: group B
arm group label: group C
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: HIV Infections