ID

42097

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00354627

Link

http://clinicaltrials.gov/show/NCT00354627

Stichworte

  1. 13.03.12 13.03.12 -
  2. 14.04.14 14.04.14 - Julian Varghese
  3. 09.04.21 09.04.21 - Ahmed Rafee, MD
Rechteinhaber

AR

Hochgeladen am

9. April 2021

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility NCT00354627 HIV-1

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beschreibung

    Einschlusskriterien

    Patient mindestens 18 Jahre alt
    Beschreibung

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
    Beschreibung

    Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])

    Datentyp

    boolean

    Alias
    UMLS CUI 1
    C0011900
    SNOMED CT 1
    439401001
    LOINC 1
    MTHU008876
    UMLS CUI 2
    C0019693
    SNOMED CT 2
    86406008
    MedDRA 1
    10020161
    LOINC Version 232
    MTHU020829
    ICD-10-CM Version 2010
    B20
    ICD-9-CM Version 2011
    042
    UMLS CUI 3
    C0013227
    UMLS CUI 4
    C1527415
    SNOMED CT 3
    26643006
    HL7 V3 2006_05
    _OralRoute
    UMLS CUI 5
    C1963724
    MedDRA 2
    10067326
    LOINC 2
    MTHU000163
    UMLS CUI 6
    C1373111
    UMLS CUI 7
    C0033607
    SNOMED CT 4
    412127001
    UMLS CUI 8
    C1373120
    Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
    Beschreibung

    Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0205225
    UMLS CUI [2]
    C1373120
    UMLS CUI [3]
    C0013203
    Patient has previously received 2 different PI-based regimens
    Beschreibung

    Patient has previously received 2 different PI-based regimens

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0033607
    SNOMED CT 2011_0131
    412127001
    Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
    Beschreibung

    Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1373120
    Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
    Beschreibung

    Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.

    Datentyp

    boolean

    Alias
    UMLS CUI 1
    C1963724
    MedDRA 14.1
    10067326
    LOINC Version 232
    MTHU000163
    UMLS CUI 2
    C1320680
    SNOMED CT 2011_0131
    405786003
    Ausschlusskriterien
    Beschreibung

    Ausschlusskriterien

    Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
    Beschreibung

    Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C2348568
    Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
    Beschreibung

    Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)

    Datentyp

    boolean

    Alias
    UMLS CUI 1
    C1444657
    SNOMED CT 1
    410536001
    UMLS CUI 2
    C0521115
    SNOMED CT 2011_0131
    79970003
    UMLS CUI 3
    C0039798
    Use of investigational ARVs (with exceptions)
    Beschreibung

    Use of investigational ARVs (with exceptions)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0013230
    Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
    Beschreibung

    Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase

    Datentyp

    boolean

    Alias
    UMLS CUI 1
    C0205164
    SNOMED CT 1
    255603008
    UMLS CUI 2
    C0012634
    SNOMED CT 2
    64572001
    Pregnant or breast-feeding female
    Beschreibung

    Pregnant or breast-feeding female

    Datentyp

    boolean

    Alias
    UMLS CUI 1
    C0549206
    MedDRA 1
    10036586
    UMLS CUI 2
    C0006147
    MedDRA 2
    10006247
    Female patient of childbearing potential not using effective non-hormonal birth control methods
    Beschreibung

    Female patient of childbearing potential not using effective non-hormonal birth control methods

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    Patients with specific laboratory abnormalities
    Beschreibung

    Patients with specific laboratory abnormalities

    Datentyp

    boolean

    Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
    Beschreibung

    Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1869009
    MedDRA 14.1
    20000005

    Ähnliche Modelle

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Einschlusskriterien
    age at least 18 Years
    Item
    Patient mindestens 18 Jahre alt
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
    Item
    Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
    boolean
    C0011900 (UMLS CUI 1)
    439401001 (SNOMED CT 1)
    MTHU008876 (LOINC 1)
    C0019693 (UMLS CUI 2)
    86406008 (SNOMED CT 2)
    10020161 (MedDRA 1)
    MTHU020829 (LOINC Version 232)
    B20 (ICD-10-CM Version 2010)
    042 (ICD-9-CM Version 2011)
    C0013227 (UMLS CUI 3)
    C1527415 (UMLS CUI 4)
    26643006 (SNOMED CT 3)
    _OralRoute (HL7 V3 2006_05)
    C1963724 (UMLS CUI 5)
    10067326 (MedDRA 2)
    MTHU000163 (LOINC 2)
    C1373111 (UMLS CUI 6)
    C0033607 (UMLS CUI 7)
    412127001 (SNOMED CT 4)
    C1373120 (UMLS CUI 8)
    Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
    Item
    Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
    boolean
    C0205225 (UMLS CUI [1])
    C1373120 (UMLS CUI [2])
    C0013203 (UMLS CUI [3])
    Patient has previously received 2 different PI-based regimens
    Item
    Patient has previously received 2 different PI-based regimens
    boolean
    C0033607 (UMLS CUI 2011AA)
    412127001 (SNOMED CT 2011_0131)
    Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
    Item
    Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
    boolean
    C1373120 (UMLS CUI 2011AA)
    Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
    Item
    Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
    boolean
    C1963724 (UMLS CUI 1)
    10067326 (MedDRA 14.1)
    MTHU000163 (LOINC Version 232)
    C1320680 (UMLS CUI 2)
    405786003 (SNOMED CT 2011_0131)
    Item Group
    Ausschlusskriterien
    Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
    Item
    Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
    boolean
    C2348568 (UMLS CUI 2011AA)
    Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
    Item
    Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
    boolean
    C1444657 (UMLS CUI 1)
    410536001 (SNOMED CT 1)
    C0521115 (UMLS CUI 2)
    79970003 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 3)
    Use of investigational ARVs (with exceptions)
    Item
    Use of investigational ARVs (with exceptions)
    boolean
    C0013230 (UMLS CUI 2011AA)
    Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
    Item
    Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
    boolean
    C0205164 (UMLS CUI 1)
    255603008 (SNOMED CT 1)
    C0012634 (UMLS CUI 2)
    64572001 (SNOMED CT 2)
    Pregnant or breast-feeding female
    Item
    Pregnant or breast-feeding female
    boolean
    C0549206 (UMLS CUI 1)
    10036586 (MedDRA 1)
    C0006147 (UMLS CUI 2)
    10006247 (MedDRA 2)
    Female patient of childbearing potential not using effective non-hormonal birth control methods
    Item
    Female patient of childbearing potential not using effective non-hormonal birth control methods
    boolean
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    Patients with specific laboratory abnormalities
    Item
    Patients with specific laboratory abnormalities
    boolean
    Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
    Item
    Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
    boolean
    C1869009 (UMLS CUI 2011AA)
    20000005 (MedDRA 14.1)

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