<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/NCT03306251</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS-CO11-EPF</org_study_id>
    <nct_id>NCT03306251</nct_id>
  </id_info>
  <brief_title>National Cohort of Children Born to HIV-positive Mothers</brief_title>
  <acronym>EPF</acronym>
  <official_title>ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide a surveillance system to monitor changes in the rate&#xD;
      of mother to child HIV transmission and preventive practices in France and especially to&#xD;
      identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to&#xD;
      monitor changes in the rate of mother to child transmission and preventive practices in&#xD;
      France and especially to identify the occurrence of toxicity in children exposed perinatally&#xD;
      to antiretroviral drugs.&#xD;
&#xD;
      The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1&#xD;
      maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM).&#xD;
&#xD;
      Maternal clinical, biological and therapeutic data before and during pregnancy were collected&#xD;
      at delivery, with simplified questionnaires.&#xD;
&#xD;
      The children are examined clinically and biologically at birth, 6, 12 and 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2005</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV</measure>
    <time_frame>At birth up to 24 months</time_frame>
    <description>Number of infected children (HIV RNA &gt;50c/mL or Positive serology) reported on the total number of children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immuno-virological response during pregnancy</measure>
    <time_frame>At inclusion up to childbirth</time_frame>
    <description>HIV ARN &lt;50c/mL, CD4 cells count&gt;500 cells/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy</measure>
    <time_frame>At inclusion up to childbirth</time_frame>
    <description>incidence of pathologies during pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of different kind of MTCT prophylaxis on childbirth</measure>
    <time_frame>At delivery</time_frame>
    <description>Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children</measure>
    <time_frame>At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months</time_frame>
    <description>Clinical abnormalities (occurrence of adverse events)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5200</enrollment>
  <condition>Mother to Child Transmission of HIV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion as soon as possible during pregnancy of HIV-women in obstetrical sites (15 sites&#xD;
        in Paris area, 35 in mainland France and 4 in the DOM)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women &gt;= 18 years&#xD;
&#xD;
          -  infected with HIV1 and/or HIV2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  guardianship or judicial or administrative detention&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josiane WARSZAWSKI</last_name>
    <role>Principal Investigator</role>
    <affiliation>CESP INSERM U1018</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Josiane WARSZAWSKI</last_name>
    <email>josiane.warszawski@inserm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maud BROSSARD</last_name>
    <email>maud.brossard@inserm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Hôpital Nord</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Luc SCHMIT</last_name>
    </contact>
    <investigator>
      <last_name>Jean-Luc SCHMIT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascale FIALAIRE</last_name>
    </contact>
    <investigator>
      <last_name>Pascale FIALAIRE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hosipitalier</name>
      <address>
        <city>Annecy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Virginie Vitrat</last_name>
    </contact>
    <investigator>
      <last_name>Virginie Vitrat</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Robert Ballanger</name>
      <address>
        <city>Aulnay</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Anne BOULDOUYRE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général de Bastia</name>
      <address>
        <city>Bastia</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice Moulin</last_name>
    </contact>
    <investigator>
      <last_name>Alice Moulin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Côte Basque</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudine CAYLA</last_name>
    </contact>
    <investigator>
      <last_name>Claudine CAYLA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU Saint Jacques</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine CHIROUZE</last_name>
    </contact>
    <investigator>
      <last_name>Catherine CHIROUZE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe Elleau</last_name>
    </contact>
    <investigator>
      <last_name>Christophe Elleau</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional Universitaire de Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Séverine ANSART</last_name>
    </contact>
    <investigator>
      <last_name>Séverine ANSART</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Béziers</name>
      <address>
        <city>Béziers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gilles PALENZUELA</last_name>
    </contact>
    <investigator>
      <last_name>Gilles PALENZUELA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU Clemenceau</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacques BROUARD</last_name>
    </contact>
    <investigator>
      <last_name>Jacques BROUARD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier William Morey</name>
      <address>
        <city>Chalon sur Saone</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandrine Anne MARTHA</last_name>
    </contact>
    <investigator>
      <last_name>Sandrine Anne MARTHA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Creil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bénédicte Carpentier</last_name>
    </contact>
    <investigator>
      <last_name>Bénédicte Carpentier</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Etienne Dienga</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire BRIANDET</last_name>
    </contact>
    <investigator>
      <last_name>Claire BRIANDET</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Evreux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johnson AMA</last_name>
    </contact>
    <investigator>
      <last_name>Johnson AMA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Fontainebleau</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corinne ROUTIER</last_name>
    </contact>
    <investigator>
      <last_name>Corinne ROUTIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Les Oudayries</name>
      <address>
        <city>La Roche sur Yon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas GUIMARD</last_name>
    </contact>
    <investigator>
      <last_name>Thomas GUIMARD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Lagny</name>
      <address>
        <city>Lagny sur Marne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armand CHALVON-DEMERSAY</last_name>
    </contact>
    <investigator>
      <last_name>Armand CHALVON-DEMERSAY</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital André Mignot, Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Véronique HENTGEN</last_name>
    </contact>
    <investigator>
      <last_name>Véronique HENTGEN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire GENET</last_name>
    </contact>
    <investigator>
      <last_name>Claire GENET</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Longjumeau</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hervé SEAUME</last_name>
    </contact>
    <investigator>
      <last_name>Hervé SEAUME</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bretagne Sud</name>
      <address>
        <city>Lorient</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathilde Niault</last_name>
    </contact>
    <investigator>
      <last_name>Mathilde Niault</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier François Quesnay</name>
      <address>
        <city>Mantes la Jolie</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed JABBAR</last_name>
    </contact>
    <investigator>
      <last_name>Ahmed JABBAR</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Meaux</name>
      <address>
        <city>Maux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leila KARAOUI</last_name>
    </contact>
    <investigator>
      <last_name>Leila KARAOUI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Marc Jacquet</name>
      <address>
        <city>Melun</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isolde PAULY-RAVELLY</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal</name>
      <address>
        <city>Montfermeil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion Dehlinger-Paul</last_name>
    </contact>
    <investigator>
      <last_name>Marion Dehlinger-Paul</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire HUBERT</last_name>
    </contact>
    <investigator>
      <last_name>Claire HUBERT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Caremeau</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joëlle DENDALE-NGUYEN</last_name>
    </contact>
    <investigator>
      <last_name>Joëlle DENDALE-NGUYEN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evelyne WERNER</last_name>
    </contact>
    <investigator>
      <last_name>Evelyne WERNER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Orsay</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DE GENNES</last_name>
    </contact>
    <investigator>
      <last_name>DE GENNES</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bon secours-Saint Joseph</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion Dehlinger-Paul</last_name>
    </contact>
    <investigator>
      <last_name>Marion Dehlinger-Paul</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHG Maréchal Joffre</name>
      <address>
        <city>Perpignan</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie MEDUS</last_name>
    </contact>
    <investigator>
      <last_name>Marie MEDUS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal</name>
      <address>
        <city>Poissy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie COUDERC</last_name>
    </contact>
    <investigator>
      <last_name>Sophie COUDERC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier René Dubos</name>
      <address>
        <city>Pontoise</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amine YANGUI</last_name>
    </contact>
    <investigator>
      <last_name>Amine YANGUI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Léon Binet</name>
      <address>
        <city>Provins</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed ABDELHADI</last_name>
    </contact>
    <investigator>
      <last_name>Mohamed ABDELHADI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Laennec</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal PERFEZOU</last_name>
    </contact>
    <investigator>
      <last_name>Pascal PERFEZOU</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHR American Memorial Hospital</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire PLUCHART</last_name>
    </contact>
    <investigator>
      <last_name>Claire PLUCHART</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cedric ARVIEUX</last_name>
    </contact>
    <investigator>
      <last_name>Cedric ARVIEUX</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Didier PINQUIER</last_name>
    </contact>
    <investigator>
      <last_name>Didier PINQUIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hopsitalier Yves Le Foll</name>
      <address>
        <city>Saint Brieuc</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corinne DANIEL</last_name>
    </contact>
    <investigator>
      <last_name>Corinne DANIEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bellevue</name>
      <address>
        <city>Saint Etienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kareen BILLEMAZ</last_name>
    </contact>
    <investigator>
      <last_name>Kareen BILLEMAZ</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier</name>
      <address>
        <city>Saint Julien</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emilie PIET</last_name>
    </contact>
    <investigator>
      <last_name>Emilie PIET</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint Nazaire-Cité Sanitaire</name>
      <address>
        <city>Saint Nazaire</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe Michaud</last_name>
    </contact>
    <investigator>
      <last_name>Christophe Michaud</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de Saint-Martin</name>
      <address>
        <city>Saint-Martin</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyril CLAVEL</last_name>
    </contact>
    <investigator>
      <last_name>Cyril CLAVEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Font Pré</name>
      <address>
        <city>Toulon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gilles HITTINGER</last_name>
    </contact>
    <investigator>
      <last_name>Gilles HITTINGER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU de Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louis BERNARD</last_name>
    </contact>
    <investigator>
      <last_name>Louis BERNARD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bretagne Atlantique</name>
      <address>
        <city>Vannes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yves POINSIGNON</last_name>
    </contact>
    <investigator>
      <last_name>Yves POINSIGNON</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier</name>
      <address>
        <city>Vernon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahfoud ROUHA</last_name>
    </contact>
    <investigator>
      <last_name>Mahfoud ROUHA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal</name>
      <address>
        <city>Villeneuve Saint Georges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne CHACE</last_name>
    </contact>
    <investigator>
      <last_name>Anne CHACE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHG de Cayenne</name>
      <address>
        <city>Cayenne</city>
        <country>French Guiana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Narcisse ELENGA</last_name>
    </contact>
    <investigator>
      <last_name>Narcisse ELENGA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Pointe à Pitre, Les Abymes</name>
      <address>
        <city>Pointe à Pitre</city>
        <country>Guadeloupe</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Blandine MUANZA</last_name>
    </contact>
    <investigator>
      <last_name>Blandine MUANZA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Victor Fouche</name>
      <address>
        <city>Fort de France</city>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yves HATCHUEL</last_name>
    </contact>
    <investigator>
      <last_name>Yves HATCHUEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
    <country>French Guiana</country>
    <country>Guadeloupe</country>
    <country>Martinique</country>
  </location_countries>
  <results_reference>
    <citation>Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.</citation>
    <PMID>26197844</PMID>
  </results_reference>
  <results_reference>
    <citation>Taron-Brocard C, Le Chenadec J, Faye A, Dollfus C, Goetghebuer T, Gajdos V, Labaune JM, Perilhou A, Mandelbrot L, Blanche S, Warszawski J; France REcherche Nord&amp;Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group. Increased risk of serious bacterial infections due to maternal immunosuppression in HIV-exposed uninfected infants in a European country. Clin Infect Dis. 2014 Nov 1;59(9):1332-45. doi: 10.1093/cid/ciu586. Epub 2014 Jul 22.</citation>
    <PMID>25053719</PMID>
  </results_reference>
  <results_reference>
    <citation>Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A, Dollfus C, Tubiana R, Bonnet D, Lelong N, Khoshnood B, Warszawski J. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014 Apr 29;11(4):e1001635. doi: 10.1371/journal.pmed.1001635. eCollection 2014 Apr.</citation>
    <PMID>24781315</PMID>
  </results_reference>
  <results_reference>
    <citation>Briand N, Jasseron C, Sibiude J, Azria E, Pollet J, Hammou Y, Warszawski J, Mandelbrot L. Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000-2010. Am J Obstet Gynecol. 2013 Oct;209(4):335.e1-335.e12. doi: 10.1016/j.ajog.2013.06.021. Epub 2013 Jun 18.</citation>
    <PMID>23791563</PMID>
  </results_reference>
  <results_reference>
    <citation>Briand N, Warszawski J, Mandelbrot L, Dollfus C, Pannier E, Cravello L, Nguyen R, Matheron I, Winer N, Tubiana R, Rouzioux C, Faye A, Blanche S; ANRS-EPF CO1-CO11 Study Group. Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era? Clin Infect Dis. 2013 Sep;57(6):903-14. doi: 10.1093/cid/cit374. Epub 2013 May 31.</citation>
    <PMID>23728147</PMID>
  </results_reference>
  <results_reference>
    <citation>Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.</citation>
    <PMID>23079802</PMID>
  </results_reference>
  <results_reference>
    <citation>Jasseron C, Mandelbrot L, Dollfus C, Trocme N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J. Non-disclosure of a pregnant woman's HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav. 2013 Feb;17(2):488-97. doi: 10.1007/s10461-011-0084-y.</citation>
    <PMID>22130651</PMID>
  </results_reference>
  <results_reference>
    <citation>Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Treluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011 Jul 6;306(1):70-8. doi: 10.1001/jama.2011.915.</citation>
    <PMID>21730243</PMID>
  </results_reference>
  <results_reference>
    <citation>Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C, Teglas JP, Ekoukou D, Blanche S, Mandelbrot L. Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis. 2012 May;54(9):1348-60. doi: 10.1093/cid/cis198. Epub 2012 Mar 28.</citation>
    <PMID>22460969</PMID>
  </results_reference>
  <results_reference>
    <citation>Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load &lt;500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.</citation>
    <PMID>20070234</PMID>
  </results_reference>
  <results_reference>
    <citation>Briand N, Mandelbrot L, Le Chenadec J, Tubiana R, Teglas JP, Faye A, Dollfus C, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. No relation between in-utero exposure to HAART and intrauterine growth retardation. AIDS. 2009 Jun 19;23(10):1235-43. doi: 10.1097/QAD.0b013e32832be0df.</citation>
    <PMID>19424054</PMID>
  </results_reference>
  <results_reference>
    <citation>Mandelbrot L, Jasseron C, Ekoukou D, Batallan A, Bongain A, Pannier E, Blanche S, Tubiana R, Rouzioux C, Warszawski J; ANRS French Perinatal Cohort (EPF). Amniocentesis and mother-to-child human immunodeficiency virus transmission in the Agence Nationale de Recherches sur le SIDA et les Hepatites Virales French Perinatal Cohort. Am J Obstet Gynecol. 2009 Feb;200(2):160.e1-9. doi: 10.1016/j.ajog.2008.08.049. Epub 2008 Nov 4.</citation>
    <PMID>18986640</PMID>
  </results_reference>
  <results_reference>
    <citation>Jasseron C, Mandelbrot L, Tubiana R, Teglas JP, Faye A, Dollfus C, Le Chenadec J, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. Prevention of mother-to-child HIV transmission: similar access for sub-Sahara African immigrants and for French women? AIDS. 2008 Jul 31;22(12):1503-11. doi: 10.1097/QAD.0b013e3283065b8c.</citation>
    <PMID>18614874</PMID>
  </results_reference>
  <results_reference>
    <citation>Benhammou V, Warszawski J, Bellec S, Doz F, Andre N, Lacour B, Levine M, Bavoux F, Tubiana R, Mandelbrot L, Clavel J, Blanche S; ANRS-Enquete Perinatale Francaise. Incidence of cancer in children perinatally exposed to nucleoside reverse transcriptase inhibitors. AIDS. 2008 Oct 18;22(16):2165-77. doi: 10.1097/QAD.0b013e328311d18b. Erratum In: AIDS. 2012 May 15;26(8):1047. Carbillon, Francois F [corrected to Carbillon, L].</citation>
    <PMID>18832880</PMID>
  </results_reference>
  <results_reference>
    <citation>Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus C, Faye A, Burgard M, Rouzioux C, Mandelbrot L; ANRS French Perinatal Cohort. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS. 2008 Jan 11;22(2):289-99. doi: 10.1097/QAD.0b013e3282f3d63c.</citation>
    <PMID>18097232</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 20, 2016</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Prevention of mother-to-child transmission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</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/NCT03306251
org study id: ANRS-CO11-EPF
nct id: NCT03306251
lead sponsor: 
has dmc: No
The purpose of this study is to provide a surveillance system to monitor changes in the rate
      of mother to child HIV transmission and preventive practices in France and especially to
      identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.
The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to
      monitor changes in the rate of mother to child transmission and preventive practices in
      France and especially to identify the occurrence of toxicity in children exposed perinatally
      to antiretroviral drugs.

      The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1
      maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM).

      Maternal clinical, biological and therapeutic data before and during pregnancy were collected
      at delivery, with simplified questionnaires.

      The children are examined clinically and biologically at birth, 6, 12 and 24 months.
observational model: Cohort
time perspective: Prospective
measure: Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
time frame: At birth up to 24 months
description: Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children
measure: Immuno-virological response during pregnancy
time frame: At inclusion up to childbirth
description: HIV ARN <50c/mL, CD4 cells count>500 cells/mL
measure: Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
time frame: At inclusion up to childbirth
description: incidence of pathologies during pregnancy
measure: Impact of different kind of MTCT prophylaxis on childbirth
time frame: At delivery
description: Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)
measure: Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children
time frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months
description: Clinical abnormalities (occurrence of adverse events)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josiane WARSZAWSKI
role: Principal Investigator
affiliation: CESP INSERM U1018
last name: Josiane WARSZAWSKI
email: josiane.warszawski@inserm.fr
last name: Maud BROSSARD
email: maud.brossard@inserm.fr
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country: France
country: French Guiana
country: Guadeloupe
country: Martinique
citation: Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.
PMID: 26197844
citation: Taron-Brocard C, Le Chenadec J, Faye A, Dollfus C, Goetghebuer T, Gajdos V, Labaune JM, Perilhou A, Mandelbrot L, Blanche S, Warszawski J; France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group. Increased risk of serious bacterial infections due to maternal immunosuppression in HIV-exposed uninfected infants in a European country. Clin Infect Dis. 2014 Nov 1;59(9):1332-45. doi: 10.1093/cid/ciu586. Epub 2014 Jul 22.
PMID: 25053719
citation: Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A, Dollfus C, Tubiana R, Bonnet D, Lelong N, Khoshnood B, Warszawski J. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014 Apr 29;11(4):e1001635. doi: 10.1371/journal.pmed.1001635. eCollection 2014 Apr.
PMID: 24781315
citation: Briand N, Jasseron C, Sibiude J, Azria E, Pollet J, Hammou Y, Warszawski J, Mandelbrot L. Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000-2010. Am J Obstet Gynecol. 2013 Oct;209(4):335.e1-335.e12. doi: 10.1016/j.ajog.2013.06.021. Epub 2013 Jun 18.
PMID: 23791563
citation: Briand N, Warszawski J, Mandelbrot L, Dollfus C, Pannier E, Cravello L, Nguyen R, Matheron I, Winer N, Tubiana R, Rouzioux C, Faye A, Blanche S; ANRS-EPF CO1-CO11 Study Group. Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era? Clin Infect Dis. 2013 Sep;57(6):903-14. doi: 10.1093/cid/cit374. Epub 2013 May 31.
PMID: 23728147
citation: Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.
PMID: 23079802
citation: Jasseron C, Mandelbrot L, Dollfus C, Trocme N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J. Non-disclosure of a pregnant woman's HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav. 2013 Feb;17(2):488-97. doi: 10.1007/s10461-011-0084-y.
PMID: 22130651
citation: Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Treluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011 Jul 6;306(1):70-8. doi: 10.1001/jama.2011.915.
PMID: 21730243
citation: Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C, Teglas JP, Ekoukou D, Blanche S, Mandelbrot L. Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis. 2012 May;54(9):1348-60. doi: 10.1093/cid/cis198. Epub 2012 Mar 28.
PMID: 22460969
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PMID: 18832880
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PMID: 18097232
responsible party type: Sponsor
mesh term: HIV Seropositivity