0 Evaluaciones
ID

39891

Descripción

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

Palabras clave

Versiones (1)
  1. 29/2/20 29/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility HIV NCT01258439

    Inglés

    Eligibility HIV NCT01258439

    1 formularios  
    1. StudyEvent: Eligibility
      1. Eligibility HIV NCT01258439
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    provision of signed, informed consent
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    age >18 years
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    hiv infection documented by hiv antibody test and western blot prior to study entry
    Descripción

    HIV Infections | HIV Antibody Measurement | Western blot for HIV

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C3714540
    UMLS CUI [3]
    C0860963
    no previous art or no art for 6 months prior to randomisation
    Descripción

    Antiretroviral therapy Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1963724
    UMLS CUI [1,2]
    C0332197
    cd4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
    Descripción

    CD4+ Count | Viral load measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0243009
    UMLS CUI [2]
    C1261478
    no genotypic resistance to raltegravir, tenofovir/emtricitabine, darunavir, ritonavir
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C1514892
    UMLS CUI [1,3]
    C0017431
    UMLS CUI [1,4]
    C1871526
    UMLS CUI [2,1]
    C0332197
    UMLS CUI [2,2]
    C1514892
    UMLS CUI [2,3]
    C0017431
    UMLS CUI [2,4]
    C0384228
    UMLS CUI [3,1]
    C0332197
    UMLS CUI [3,2]
    C1514892
    UMLS CUI [3,3]
    C0017431
    UMLS CUI [3,4]
    C0909839
    UMLS CUI [4,1]
    C0332197
    UMLS CUI [4,2]
    C1514892
    UMLS CUI [4,3]
    C0017431
    UMLS CUI [4,4]
    C1435444
    UMLS CUI [5,1]
    C0332197
    UMLS CUI [5,2]
    C1514892
    UMLS CUI [5,3]
    C0017431
    UMLS CUI [5,4]
    C0292818
    body mass index less than 30kg/m2
    Descripción

    Body mass index

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    primary hiv infection within the last 6 months
    Descripción

    Primary HIV infection Recent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1142553
    UMLS CUI [1,2]
    C0332185
    active infection or opportunistic illness within the previous 30 days
    Descripción

    Communicable Disease Recent | Opportunistic Infection Recent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C0029118
    UMLS CUI [2,2]
    C0332185
    use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
    Descripción

    Pharmaceutical Preparation Contraindicated Darunavir+Ritonavir | Pharmaceutical Preparation Contraindicated Raltegravir

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1444657
    UMLS CUI [1,3]
    C1976853
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C1444657
    UMLS CUI [2,3]
    C1871526
    use of lipid-lowering therapy
    Descripción

    Lipid-lowering therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0585943
    diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
    Descripción

    Diabetes Mellitus | Glucose measurement, fasting

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    UMLS CUI [2]
    C0202045
    use of oral prednisolone > 7.5mg daily or equivalent
    Descripción

    Oral prednisolone U/day | Equivalent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0358513
    UMLS CUI [1,2]
    C0456683
    UMLS CUI [2]
    C0205163
    pregnancy or breast feeding
    Descripción

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    proven hypersensitivity to one or more components of the study meal
    Descripción

    Hypersensitivity Component Study Meal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1705248
    UMLS CUI [1,3]
    C0008972
    UMLS CUI [1,4]
    C1998602
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    Similar models

    Eligibility HIV NCT01258439

    1 formularios
    1. StudyEvent: Eligibility
      1. Eligibility HIV NCT01258439
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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