<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/NCT02203006</url>
  </required_header>
  <id_info>
    <org_study_id>IDRCB : 2010-A00417-32</org_study_id>
    <nct_id>NCT02203006</nct_id>
  </id_info>
  <brief_title>HIV Patients Cohort</brief_title>
  <acronym>OVIHD</acronym>
  <official_title>Constitution of an Open Monocentric Cohort of HIV Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve our knowledge concerning HIV infection, treated or&#xD;
      not, in the current conditions of care to optimize it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory&#xD;
      chronic pathology centred on a long term care taking into account the complication of&#xD;
      long-term treatment as well as the arisen of new problem bound to a prolonged survival and&#xD;
      ageing. So the care is more and more in a prevention and screening approach with in&#xD;
      particular the care of metabolic and cardiovascular complication due to antiretroviral&#xD;
      treatment.&#xD;
&#xD;
      As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu&#xD;
      Hospital it thus seems important to double this care optimization with a clinical research&#xD;
      side. This will be done in constituting an HIV patient cohort including a blood sample&#xD;
      collection to contribute to the vigilance of the complication to due the infection.&#xD;
&#xD;
      Our ultimate objective is to optimize the selection of the treatment. It is important to do&#xD;
      it to be able to have, on many years duration, precise clinical information and biological&#xD;
      sample allowing to realize later some assay and analyse the influence of some genetic&#xD;
      markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 19, 2011</start_date>
  <completion_date type="Anticipated">April 2031</completion_date>
  <primary_completion_date type="Anticipated">October 2030</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV infection</measure>
    <time_frame>10 years</time_frame>
    <description>The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comorbidity and complication in HIV infected patients</measure>
    <time_frame>10 years</time_frame>
    <description>The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>efficiency of the current antiretroviral therapeutic diets</measure>
    <time_frame>10 years</time_frame>
    <description>The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sample collection</measure>
    <time_frame>10 years</time_frame>
    <description>To put in relation the clinical-biological relevant biological or genetic data of the follow-up a blood sample will be constituted. 7 ml will be taken to each patient and kept in a collection</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1613</enrollment>
  <condition>Patients Affected by the HIV</condition>
  <arm_group>
    <arm_group_label>OVIHD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cohort and a blood sample collection will be done with data and blood of HIV infected patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>OVIHD</intervention_name>
    <description>7 ml of blood will be taken during a follow-up consultation and kept in a biological collection. Clinical data will be collected in a database.</description>
    <arm_group_label>OVIHD</arm_group_label>
    <other_name>Blood sample</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥18 years old,&#xD;
&#xD;
          -  Patients with an HIV infection&#xD;
&#xD;
          -  patients having given their written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marc Tréluyer, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Hôtel Dieu</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV,</keyword>
  <keyword>infection,</keyword>
  <keyword>cohort</keyword>
  <!-- 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/NCT02203006
org study id: IDRCB : 2010-A00417-32
nct id: NCT02203006
lead sponsor: 
has dmc: No
The purpose of this study is to improve our knowledge concerning HIV infection, treated or
      not, in the current conditions of care to optimize it.
Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory
      chronic pathology centred on a long term care taking into account the complication of
      long-term treatment as well as the arisen of new problem bound to a prolonged survival and
      ageing. So the care is more and more in a prevention and screening approach with in
      particular the care of metabolic and cardiovascular complication due to antiretroviral
      treatment.

      As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu
      Hospital it thus seems important to double this care optimization with a clinical research
      side. This will be done in constituting an HIV patient cohort including a blood sample
      collection to contribute to the vigilance of the complication to due the infection.

      Our ultimate objective is to optimize the selection of the treatment. It is important to do
      it to be able to have, on many years duration, precise clinical information and biological
      sample allowing to realize later some assay and analyse the influence of some genetic
      markers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: HIV infection
time frame: 10 years
description: The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
measure: Comorbidity and complication in HIV infected patients
time frame: 10 years
description: The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
measure: efficiency of the current antiretroviral therapeutic diets
time frame: 10 years
description: The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
measure: Blood sample collection
time frame: 10 years
description: To put in relation the clinical-biological relevant biological or genetic data of the follow-up a blood sample will be constituted. 7 ml will be taken to each patient and kept in a collection
arm group label: OVIHD
arm group type: Other
description: Cohort and a blood sample collection will be done with data and blood of HIV infected patients
intervention type: Biological
intervention name: OVIHD
description: 7 ml of blood will be taken during a follow-up consultation and kept in a biological collection. Clinical data will be collected in a database.
arm group label: OVIHD
other name: Blood sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marc Tréluyer, MD, PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor