<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF60024-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of HIV-infected patients who began treatment with protease inhibitor in 1997-1999. Follow-up over 4 years on the long-term effects linked with adherence and tolerance (COPILOT).</titl>
      <IDNo>FRESH-PEF60024-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)" role="">Catherine LEPORT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of HIV-infected patients who began treatment with protease inhibitor in 1997-1999. Follow-up over 4 years on the long-term effects linked with adherence and tolerance (COPILOT).            </titl>
      <altTitl>
                    ANRS CO8 APROCO-COPILOTE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60024-en            </IDNo>
      <IDNo agency="PEF">
                    60024                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60024                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Catherine LEPORT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)">
        <ExtLink title="ROR" URI="https://ror.org/01kv58h76" role="organisation id"/>
        <ExtLink title="SIREN" URI="180089385" 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>
                                            ABBOTT FRANCE                    
                                    </fundAg>
      <fundAg>
                                            BOEHRINGER INGELHEIM INTERNATIONAL GMBH                    
                                    </fundAg>
      <fundAg>
                                            BRISTOL MYERS SQUIBB PHARMA FRANCE S.A                    
                                    </fundAg>
      <fundAg>
                                            COLLEGE DES UNIVERSITAIRES DE MALADIES INFECTIEUSES ET TROPICALES (CMIT)                    
                                    </fundAg>
      <fundAg>
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </fundAg>
      <fundAg>
                                            GILEAD SCIENCES                    
                                    </fundAg>
      <fundAg>
                                            GLAXOSMITHKLINE (FRANCE)                    
                                    </fundAg>
      <fundAg>
                                            PFIZER (FRANCE)                    
                                    </fundAg>
      <fundAg>
                                            SIDACTION (ECS)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    unexpected events</keyword>
      <keyword vocab="" vocabURI="">
                    Observed health events</keyword>
      <keyword vocab="" vocabURI="">
                    serious adverse events</keyword>
      <keyword vocab="" vocabURI="">
                    cardiovascular risk factors</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">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: To investigate determinants for long-term effects of adherence and tolerance to highly active antiretroviral drugs, in relation to patients infected with HIV-1 who were treated for the first time under a protease inhibitor in 1997-99. Secondary objectives: - to determine the part that host genetic polymorphisms play in the progression of the infection and onset of serious adverse events - to investigate viral load and antiretroviral resistance in plasma cell compartments in relation to antiretroviral concentrations over time.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2003-01-01"/>
      <collDate event="end" date="2009-01-01"/>
      <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 clusion="I">Patients included in the APROCO cohort (adults infected with HIV-1 at first prescription of protease inhibitor in 1997-99), monitored for four years in APROCO after initial enrolment, monitored by voluntary services in order to participate in extended follow-up, having given their written consent.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Anthropometry</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
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>717: Copilote 1281: Aproco</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Data may be used by academic teams Data may not be used by industrial teams</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
