<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/NCT03235310</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS-CO1-EPF</org_study_id>
    <nct_id>NCT03235310</nct_id>
  </id_info>
  <brief_title>Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention</brief_title>
  <acronym>EPF</acronym>
  <official_title>ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French National Agency for Research on AIDS and Viral Hepatitis</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 describe over time the rate of mother to child transmission&#xD;
      of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate&#xD;
      the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CO1-EPF prospectively enrolled HIV-infected women who deliver in 25 centers throughout&#xD;
      France, except in case of refusal.&#xD;
&#xD;
      Maternal clinical, biological and therapeutic data before and during pregnancy are collected&#xD;
      at delivery. The children are examined clinically and biologically at birth, 1, 3, 6, 12 and&#xD;
      24 months. An infant is considered as non infected if two virologic tests are negative beyond&#xD;
      the prophylactic treatment or serology is negative after 18 months. An infant is considered&#xD;
      as infected if HIV1 is detected by virologic tests on two occasions (polymerase chain&#xD;
      reactions, viral culture or p24 antigenemia) and if anti-HIV1 antibodies (ELISA and Western&#xD;
      blot) persist after 18 months of age. Follow up is stopped at 24 months for uninfected&#xD;
      infants whereas infected infants are enrolled in the CO10 EPF paediatric cohort. No specific&#xD;
      recommendation for HIV treatment and obstetrical care are made for women and children&#xD;
      included in the cohort, although national guidelines for prevention of MTCT are regularly&#xD;
      published and updated. Frozen maternal samples blood and plasma are stored in a centralized&#xD;
      laboratory. A research of patients patients lost to follow-up (last visit &lt;24 months) and&#xD;
      monitoring is performed regularly in all sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 1997</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, 1 month, 3 months, 6 months, 12 months and 18-24 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 (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage)</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>
  <secondary_outcome>
    <measure>Risk of mother-to-child transmission of VHC, VHB and CMV co-infections</measure>
    <time_frame>At birth, 6 months, 12 months and 18-24 months</time_frame>
    <description>Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine</description>
  </secondary_outcome>
  <enrollment type="Anticipated">18200</enrollment>
  <condition>Mother to Child Transmission of HIV</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      3 mL whole blood 3mL plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion as soon as possible during pregnancy of HIV-women in the largest obstetrical&#xD;
        sites (17 in Paris area and 8 elsewhere in mainland France)&#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;
        -&#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>
    <phone>01 49 59 53 05</phone>
    <email>josiane.warszawski@inserm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maud BROSSARD</last_name>
    <phone>01 49 59 53 13</phone>
    <email>maud.brossard@inserm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Victor Dupuy</name>
      <address>
        <city>Argenteuil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe GENET</last_name>
    </contact>
    <investigator>
      <last_name>Philippe GENET</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe BRAULT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Verdier</name>
      <address>
        <city>Bondy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric LACHASSINE</last_name>
    </contact>
    <investigator>
      <last_name>Eric LACHASSINE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amélie BENBARA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent JEANTILS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Antoine Béclère</name>
      <address>
        <city>Clamart</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Véronique CHAMBRIN</last_name>
    </contact>
    <investigator>
      <last_name>Véronique CHAMBRIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laure CLECH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de Beaujon</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre-François CECCALDI</last_name>
    </contact>
    <investigator>
      <last_name>Pierre-François CECCALDI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis Mourrier</name>
      <address>
        <city>Colombes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine CRENN-HEBERT</last_name>
    </contact>
    <investigator>
      <last_name>Catherine CRENN-HEBERT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent MANDELBROT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Corinne FLOCH TUDAL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud-Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amélie CHABROL</last_name>
    </contact>
    <investigator>
      <last_name>Amélie CHABROL</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michelle GRANIER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal</name>
      <address>
        <city>Creteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valérie GARRAIT</last_name>
    </contact>
    <investigator>
      <last_name>Valérie GARRAIT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Solène LEVET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mariem BRIKA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin Bicetre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Delphine PERETTI</last_name>
    </contact>
    <investigator>
      <last_name>Delphine PERETTI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claire COLMANT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Corinne FOURCADE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHR Jeanne de Flandres</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yamina HAMMOU</last_name>
    </contact>
    <investigator>
      <last_name>Yamina HAMMOU</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de La Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent COTTE</last_name>
    </contact>
    <investigator>
      <last_name>Laurent COTTE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Marc LABAUNE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djamila MAKHLOUFI</last_name>
    </contact>
    <investigator>
      <last_name>Djamila MAKHLOUFI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Femme Mère Enfant</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jérôme MASSARDIER</last_name>
    </contact>
    <investigator>
      <last_name>Jérôme MASSARDIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hélène GAUTHIER-MOULINIER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la conception</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludovic CRAVELLO</last_name>
    </contact>
    <investigator>
      <last_name>Ludovic CRAVELLO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHR Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuelle VINTEJOUX</last_name>
    </contact>
    <investigator>
      <last_name>Emmanuelle VINTEJOUX</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Muriel LALANDE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal</name>
      <address>
        <city>Montreuil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brigitte HELLER - ROUSSIN</last_name>
    </contact>
    <investigator>
      <last_name>Brigitte HELLER - ROUSSIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile WINTER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cécile BRUNET</last_name>
    </contact>
    <investigator>
      <last_name>Cécile BRUNET</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Véronique RELIQUET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Norbert WINER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Hôpital de l'Archet II</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>André BONGAIN</last_name>
    </contact>
    <investigator>
      <last_name>André BONGAIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fabrice MONPOUX</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Cochin Tarnier Port-Royal</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuelle PANNIER</last_name>
    </contact>
    <investigator>
      <last_name>Emmanuelle PANNIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dominique SALMON CERON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valérie MARCOU</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Necker</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marine DRIESSEN</last_name>
    </contact>
    <investigator>
      <last_name>Marine DRIESSEN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphane BLANCHE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roland TUBIANA</last_name>
    </contact>
    <investigator>
      <last_name>Roland TUBIANA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc DOMMERGUES</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frédérique QUETIN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat- Claude Bernard</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jade GHOSN</last_name>
    </contact>
    <investigator>
      <last_name>Jade GHOSN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Agnès BOURGEOIS-MOINE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elodie GUESDON</last_name>
    </contact>
    <investigator>
      <last_name>Nicole CIRARU-VIGNERON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elodie GUESDON</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne COURSOL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Debré</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Constance BORIE</last_name>
    </contact>
    <investigator>
      <last_name>Constance BORIE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Albert FAYE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lise SELLERET</last_name>
    </contact>
    <investigator>
      <last_name>Lise SELLERET</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>François HERVE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Trousseau</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine DOLLFUS</last_name>
    </contact>
    <investigator>
      <last_name>Catherine DOLLFUS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général- Hôpital Delafontaine</name>
      <address>
        <city>Saint-denis</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal BOLOT</last_name>
    </contact>
    <investigator>
      <last_name>Pascal BOLOT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amel MAHDHI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Civil / Hôpital de Haute Pierre</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Luisa PARTISANI</last_name>
    </contact>
    <investigator>
      <last_name>Maria Luisa PARTISANI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michelle WEIL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Paule de Viguier</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre DELOBEL</last_name>
    </contact>
    <investigator>
      <last_name>Pierre DELOBEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Noémie BIEZUNSKI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</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 29, 2016</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 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>
  <patient_data>
    <sharing_ipd>No</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/NCT03235310
org study id: ANRS-CO1-EPF
nct id: NCT03235310
lead sponsor: 
has dmc: No
The purpose of this study is to describe over time the rate of mother to child transmission
      of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate
      the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV
The CO1-EPF prospectively enrolled HIV-infected women who deliver in 25 centers throughout
      France, except in case of refusal.

      Maternal clinical, biological and therapeutic data before and during pregnancy are collected
      at delivery. The children are examined clinically and biologically at birth, 1, 3, 6, 12 and
      24 months. An infant is considered as non infected if two virologic tests are negative beyond
      the prophylactic treatment or serology is negative after 18 months. An infant is considered
      as infected if HIV1 is detected by virologic tests on two occasions (polymerase chain
      reactions, viral culture or p24 antigenemia) and if anti-HIV1 antibodies (ELISA and Western
      blot) persist after 18 months of age. Follow up is stopped at 24 months for uninfected
      infants whereas infected infants are enrolled in the CO10 EPF paediatric cohort. No specific
      recommendation for HIV treatment and obstetrical care are made for women and children
      included in the cohort, although national guidelines for prevention of MTCT are regularly
      published and updated. Frozen maternal samples blood and plasma are stored in a centralized
      laboratory. A research of patients patients lost to follow-up (last visit <24 months) and
      monitoring is performed regularly in all sites.
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, 1 month, 3 months, 6 months, 12 months and 18-24 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 (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage)
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)
measure: Risk of mother-to-child transmission of VHC, VHB and CMV co-infections
time frame: At birth, 6 months, 12 months and 18-24 months
description: Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine
3 mL whole blood 3mL plasma
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
phone: 01 49 59 53 05
email: josiane.warszawski@inserm.fr
last name: Maud BROSSARD
phone: 01 49 59 53 13
email: maud.brossard@inserm.fr
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country: France
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
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 <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.
PMID: 20070234
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.
PMID: 19424054
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.
PMID: 18986640
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.
PMID: 18614874
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].
PMID: 18832880
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.
PMID: 18097232
responsible party type: Sponsor
sharing ipd: No