0 Ratings
ID

39891

Description

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.; ODM derived from: https://clinicaltrials.gov/show/NCT01258439

Link

https://clinicaltrials.gov/show/NCT01258439

Keywords

Versions (1)
  1. 2/29/20 2/29/20 -
Copyright Holder

See clinicaltrials.gov

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February 29, 2020

DOI

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License

Creative Commons BY 4.0
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    Eligibility HIV NCT01258439

    English

    Eligibility HIV NCT01258439

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility HIV NCT01258439
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    provision of signed, informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    age >18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    hiv infection documented by hiv antibody test and western blot prior to study entry
    Description

    HIV Infections | HIV Antibody Measurement | Western blot for HIV

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    UMLS CUI [2]
    C3714540 (HIV Antibody Measurement)
    UMLS CUI [3]
    C0860963 (Western blot for HIV)
    no previous art or no art for 6 months prior to randomisation
    Description

    Antiretroviral therapy Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1963724 (Antiretroviral therapy)
    LOINC
    LP66375-4
    UMLS CUI [1,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    cd4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
    Description

    CD4+ Count | Viral load measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0243009 (CD4 Count determination procedure)
    UMLS CUI [2]
    C1261478 (Viral load measurement)
    SNOMED
    395058002
    no genotypic resistance to raltegravir, tenofovir/emtricitabine, darunavir, ritonavir
    Description

    Absence Resistance Genotypic Raltegravir | Absence Resistance Genotypic Tenofovir | Absence Resistance Genotypic Emtricitabine | Absence Resistance Genotypic Darunavir | Absence Resistance Genotypic Ritonavir

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [1,2]
    C1514892 (Resistance Process)
    UMLS CUI [1,3]
    C0017431 (Genotype)
    LOINC
    LP345004-8
    UMLS CUI [1,4]
    C1871526 (raltegravir)
    SNOMED
    429707008
    UMLS CUI [2,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,2]
    C1514892 (Resistance Process)
    UMLS CUI [2,3]
    C0017431 (Genotype)
    LOINC
    LP345004-8
    UMLS CUI [2,4]
    C0384228 (tenofovir)
    SNOMED
    422091007
    UMLS CUI [3,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [3,2]
    C1514892 (Resistance Process)
    UMLS CUI [3,3]
    C0017431 (Genotype)
    LOINC
    LP345004-8
    UMLS CUI [3,4]
    C0909839 (emtricitabine)
    SNOMED
    404855005
    UMLS CUI [4,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [4,2]
    C1514892 (Resistance Process)
    UMLS CUI [4,3]
    C0017431 (Genotype)
    LOINC
    LP345004-8
    UMLS CUI [4,4]
    C1435444 (darunavir)
    SNOMED
    423888002
    UMLS CUI [5,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [5,2]
    C1514892 (Resistance Process)
    UMLS CUI [5,3]
    C0017431 (Genotype)
    LOINC
    LP345004-8
    UMLS CUI [5,4]
    C0292818 (ritonavir)
    SNOMED
    108693005
    body mass index less than 30kg/m2
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    primary hiv infection within the last 6 months
    Description

    Primary HIV infection Recent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1142553 (Primary HIV infection)
    UMLS CUI [1,2]
    C0332185 (Recent)
    SNOMED
    6493001
    active infection or opportunistic illness within the previous 30 days
    Description

    Communicable Disease Recent | Opportunistic Infection Recent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C0332185 (Recent)
    SNOMED
    6493001
    UMLS CUI [2,1]
    C0029118 (Opportunistic Infections)
    SNOMED
    61274003
    UMLS CUI [2,2]
    C0332185 (Recent)
    SNOMED
    6493001
    use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
    Description

    Pharmaceutical Preparation Contraindicated Darunavir+Ritonavir | Pharmaceutical Preparation Contraindicated Raltegravir

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C1444657 (Contraindicated)
    SNOMED
    410536001
    LOINC
    LA4216-3
    UMLS CUI [1,3]
    C1976853 (darunavir and ritonavir)
    UMLS CUI [2,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [2,2]
    C1444657 (Contraindicated)
    SNOMED
    410536001
    LOINC
    LA4216-3
    UMLS CUI [2,3]
    C1871526 (raltegravir)
    SNOMED
    429707008
    use of lipid-lowering therapy
    Description

    Lipid-lowering therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0585943 (Lipid-lowering therapy)
    SNOMED
    134350008
    diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
    Description

    Diabetes Mellitus | Glucose measurement, fasting

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [2]
    C0202045 (Glucose measurement, fasting)
    SNOMED
    52302001
    use of oral prednisolone > 7.5mg daily or equivalent
    Description

    Oral prednisolone U/day | Equivalent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0358513 (prednisolone Oral Product)
    SNOMED
    349354003
    UMLS CUI [1,2]
    C0456683 (U/day)
    SNOMED
    258950000
    UMLS CUI [2]
    C0205163 (Equal)
    SNOMED
    258726008
    pregnancy or breast feeding
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    proven hypersensitivity to one or more components of the study meal
    Description

    Hypersensitivity Component Study Meal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C1705248 (Component (part))
    UMLS CUI [1,3]
    C0008972 (Clinical Research)
    UMLS CUI [1,4]
    C1998602 (Meal (occasion for eating))
    LOINC
    MTHU051571
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    Similar models

    Eligibility HIV NCT01258439

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility HIV NCT01258439
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    provision of signed, informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    age >18 years
    boolean
    C0001779 (UMLS CUI [1])
    HIV Infections | HIV Antibody Measurement | Western blot for HIV
    Item
    hiv infection documented by hiv antibody test and western blot prior to study entry
    boolean
    C0019693 (UMLS CUI [1])
    C3714540 (UMLS CUI [2])
    C0860963 (UMLS CUI [3])
    Antiretroviral therapy Absent
    Item
    no previous art or no art for 6 months prior to randomisation
    boolean
    C1963724 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    CD4+ Count | Viral load measurement
    Item
    cd4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
    boolean
    C0243009 (UMLS CUI [1])
    C1261478 (UMLS CUI [2])
    Absence Resistance Genotypic Raltegravir | Absence Resistance Genotypic Tenofovir | Absence Resistance Genotypic Emtricitabine | Absence Resistance Genotypic Darunavir | Absence Resistance Genotypic Ritonavir
    Item
    no genotypic resistance to raltegravir, tenofovir/emtricitabine, darunavir, ritonavir
    boolean
    C0332197 (UMLS CUI [1,1])
    C1514892 (UMLS CUI [1,2])
    C0017431 (UMLS CUI [1,3])
    C1871526 (UMLS CUI [1,4])
    C0332197 (UMLS CUI [2,1])
    C1514892 (UMLS CUI [2,2])
    C0017431 (UMLS CUI [2,3])
    C0384228 (UMLS CUI [2,4])
    C0332197 (UMLS CUI [3,1])
    C1514892 (UMLS CUI [3,2])
    C0017431 (UMLS CUI [3,3])
    C0909839 (UMLS CUI [3,4])
    C0332197 (UMLS CUI [4,1])
    C1514892 (UMLS CUI [4,2])
    C0017431 (UMLS CUI [4,3])
    C1435444 (UMLS CUI [4,4])
    C0332197 (UMLS CUI [5,1])
    C1514892 (UMLS CUI [5,2])
    C0017431 (UMLS CUI [5,3])
    C0292818 (UMLS CUI [5,4])
    Body mass index
    Item
    body mass index less than 30kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Primary HIV infection Recent
    Item
    primary hiv infection within the last 6 months
    boolean
    C1142553 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    Communicable Disease Recent | Opportunistic Infection Recent
    Item
    active infection or opportunistic illness within the previous 30 days
    boolean
    C0009450 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0029118 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
    Pharmaceutical Preparation Contraindicated Darunavir+Ritonavir | Pharmaceutical Preparation Contraindicated Raltegravir
    Item
    use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
    boolean
    C0013227 (UMLS CUI [1,1])
    C1444657 (UMLS CUI [1,2])
    C1976853 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2,1])
    C1444657 (UMLS CUI [2,2])
    C1871526 (UMLS CUI [2,3])
    Lipid-lowering therapy
    Item
    use of lipid-lowering therapy
    boolean
    C0585943 (UMLS CUI [1])
    Diabetes Mellitus | Glucose measurement, fasting
    Item
    diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
    boolean
    C0011849 (UMLS CUI [1])
    C0202045 (UMLS CUI [2])
    Oral prednisolone U/day | Equivalent
    Item
    use of oral prednisolone > 7.5mg daily or equivalent
    boolean
    C0358513 (UMLS CUI [1,1])
    C0456683 (UMLS CUI [1,2])
    C0205163 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnancy or breast feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Hypersensitivity Component Study Meal
    Item
    proven hypersensitivity to one or more components of the study meal
    boolean
    C0020517 (UMLS CUI [1,1])
    C1705248 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    C1998602 (UMLS CUI [1,4])
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