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<docDscr>
  <citation>
    <titlStmt>
      <titl>Observational study of the sociodemographic characteristics of patients infected with HIV B subtype versus HIV non-B subtype and having recently started their first course of antiretroviral treatment.</titl>
      <IDNo>FRESH-PEF1252-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="ABBVIE" role="">Isabelle COHEN-CODAR</producer>
    </prodStmt>
    <verStmt>
      <version></version>
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  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Observational study of the sociodemographic characteristics of patients infected with HIV B subtype versus HIV non-B subtype and having recently started their first course of antiretroviral treatment.            </titl>
      <altTitl>
                    BINOME                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF1252-en            </IDNo>
      <IDNo agency="PEF">
                    1252                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF1252                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Isabelle COHEN-CODAR                                                                                </AuthEnty>
      <AuthEnty affiliation="ABBVIE">
        <ExtLink title="SIREN" URI="750775660" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ABBOTT FRANCE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ABBOTT FRANCE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </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="">
                    anti-retroviral drug treatment (ARV)</keyword>
      <keyword vocab="" vocabURI="">
                    viral subtype</keyword>
      <keyword vocab="" vocabURI="">
                    Protease inhibitors (PI)</keyword>
      <keyword vocab="" vocabURI="">
                    non-nucleoside reverse transcriptase inhibitors (NNRTI)</keyword>
      <keyword vocab="" vocabURI="">
                    HIV</keyword>
      <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="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Describe and compare the socio-demographic characteristics of patients infected with an HIV-1 of subtype B (group 1) compared to non-B (group 2) treated with a first anti-retroviral drug treatment. Compare according to the HIV subtype the stage of the disease (clinical, viro-immunology, co-morbidities) at the time treatment is initiated, compare between the 2 groups (B and non-B) the conditions for taking the treatment and the perception by the patient of the therapy and of its effects. Identification of any correlation between these latter parameters and the change in the disease between the initiation and the first line ARV and the inclusion in the cohort: - change in the viral load (VL) according to the ARV treatment (PI, NNRTI) and of the HIV subtype (B or non-B), of the CD4, - any occurrence of clinical events, - any changes in treatments and reasons.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2008-01-01"/>
      <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="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">Age &gt; 18 years, obtaining of written consent for the collection of this personal data, patient infected by the HIV-1 virus, patient coming to consult for the first or second routine follow-up visit (i.e. 1 to 4 months) after the initiation of the ARV treatment, genotype available when the treatment is initiated.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <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>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>304</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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