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<docDscr>
  <citation>
    <titlStmt>
      <titl>Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C</titl>
      <IDNo>FRESH-PEF3626-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Laure ESTERLE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C            </titl>
      <altTitl>
                    ANRS C013 HEPAVIH                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3626-en            </IDNo>
      <IDNo agency="PEF">
                    3626                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3626                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Laure ESTERLE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Dominique SALMON                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE PARIS CITE">
        <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
        <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Philippe SOGNI                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE PARIS CITE">
        <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
        <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
      <fundAg>
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </fundAg>
      <fundAg>
                                            GLAXOSMITHKLINE (FRANCE)                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
      <fundAg>
                                            JANSSEN CILAG (JANSSEN - JOHNSON &amp;amp; JOHNSON - JOHNSON &amp;amp; JOHNSON INNOVATIVE MEDICINE)                    
                                    </fundAg>
      <fundAg>
                                            MERCK SANTE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="linda.wittkop@u-bordeaux.fr">
                    Linda;WITTKOP
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE PARIS CITE" email="dominique.salmon@aphp.fr">
                    Dominique;SALMON
                                            <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE PARIS CITE" email="philippe.sogni@aphp.fr">
                    Philippe;SOGNI
                                            <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Adults</keyword>
      <keyword vocab="" vocabURI="">
                    disease carriers</keyword>
      <keyword vocab="" vocabURI="">
                    cured</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</keyword>
      <keyword vocab="" vocabURI="">
                    co-infection</keyword>
      <topcClas vocab="health theme">
                        Clinical immunology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7a3cf568-46ba-4840-be8f-f22fc030139f"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000486"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        HIV disease clinical stage 2 without mention of tuberculosis or malaria                                            </topcClas>
      <topcClas vocab="cim-11">
                        Viral hepatitis                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Short term: - Describe patient's characteristics - Analyze factors associated to a treatment of hepatitis C: beginning of the treatment, continuation or stop of the treatment. - Validate the field performance of not-invasive markers of hepatic fibrosis. Mid-term: - Realize an observational study of the evolution of hepatitis during an anti-VHC treatment, in an antiviral situation - Study the clinical and biological tolerance to the different treatments. - Study the impact of the observance of the treatment anti HIV and the life quality of patients. Long term: Study the natural history of chronic hepatitis, in particular at the stage of cirrhosis. - Analyze the factors associated to the evolution to fibrosis, to a decompensated hepatic disease or an hepatocellular carcinoma. - Evaluate the effects of antiretroviral agents on the evolution of not-treated hepatitis - Study the potential interactions between different virus of hepatitis</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2005-01-01"/>
      <collDate event="end" date="2018-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="sex" clusion="I">Other                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Adults infected by HIV virus carriers of VHC or cured after anti-VHC treatment, or spontaneously healed without anti-VHC treatment or benefiting from an anti-VHC tritherapies.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>---</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>1849 in june 2018</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
      <complete>Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee</complete>
    </setAvail>
    <useStmt>
      <restrctn>Temporary access condition : project accepted by the scientific committee</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
