0 Evaluaciones
ID

42572

Descripción

Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00192621

Link

https://clinicaltrials.gov/show/NCT00192621

Palabras clave

Versiones (2)
  1. 2016-09-24 2016-09-24 -
  2. 2021-09-02 2021-09-02 -
Subido en

2 september 2021

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility HIV Infections NCT00192621

    Inglés

    Eligibility HIV Infections NCT00192621

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age >18
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    be able to provide written consent to perform in the trial.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    hiv antibody negative and hiv dna negative at time of entry to the study.
    Descripción

    HIV antibody negative | Human immunodeficiency virus DNA Negative

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1142096
    UMLS CUI [2,1]
    C0486959
    UMLS CUI [2,2]
    C1513916
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
    Descripción

    Mental disorders Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited | Myocardial Ischemia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [2,1]
    C3714565
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C0439801
    UMLS CUI [3]
    C0151744
    history of type i or type ii diabetes mellitus or previous treatment with antidiabetic medication.
    Descripción

    Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    UMLS CUI [2]
    C0011860
    UMLS CUI [3]
    C0935929
    prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
    Descripción

    Testosterone | Estrogens | Growth Hormone | Glucocorticoids Oral | Anabolic steroids

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0039601
    UMLS CUI [2]
    C0014939
    UMLS CUI [3]
    C0037663
    UMLS CUI [4,1]
    C0017710
    UMLS CUI [4,2]
    C1527415
    UMLS CUI [5]
    C0002845
    alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
    Descripción

    Substance Use Disorders Study Subject Participation Status Limited

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0038586
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801
    prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
    Descripción

    Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Post-Exposure Prophylaxis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0599685
    UMLS CUI [2]
    C0033607
    UMLS CUI [3]
    C1373111
    UMLS CUI [4]
    C1373120
    UMLS CUI [5,1]
    C0599685
    UMLS CUI [5,2]
    C1517586
    UMLS CUI [6]
    C1275666
    UMLS CUI [7]
    C1443861
    prior use of any retinoid-containing compound within the previous six months.
    Descripción

    Compound Containing Retinoids

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1706082
    UMLS CUI [1,2]
    C0332256
    UMLS CUI [1,3]
    C0035339
    abnormal coagulation.
    Descripción

    Blood Coagulation Disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    previous allergic reaction or known allergy to local anaesthetic.
    Descripción

    Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0002934
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0002934
    previous use of psychotropic medications.
    Descripción

    Psychotropic Drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0033978
    concomitant use of medications, including those metabolised by cyp3a4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
    Descripción

    Pharmaceutical Preparations Affecting Protocol Compliance | drug metabolism Due to CYP3A4

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0525058
    UMLS CUI [2,1]
    C0683140
    UMLS CUI [2,2]
    C0678226
    UMLS CUI [2,3]
    C1142644
    any grade-three laboratory abnormality recorded from screening bloods.
    Descripción

    Blood Screening LABORATORY ABNORMALITIES Grade

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511226
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C0441800
    any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
    Descripción

    Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511226
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C0441800
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C0439801
    gastrointestinal disorders, which may affect drug absorption.
    Descripción

    Gastrointestinal Diseases Affecting drug absorption

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0017178
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0678745
    any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
    Descripción

    screening examination Finding Study Subject Participation Status Limited

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0281974
    UMLS CUI [1,2]
    C0243095
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [1,4]
    C0439801
    pregnancy
    Descripción

    Pregnancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    evidence of acute or chronic active hepatitis b virus infection by serology performed at baseline.
    Descripción

    Hepatitis B Evidence Serologic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163
    UMLS CUI [1,2]
    C3887511
    UMLS CUI [1,3]
    C0205473
    evidence of hepatitis c infection by serology performed at baseline.
    Descripción

    Hepatitis C Evidence Serologic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196
    UMLS CUI [1,2]
    C3887511
    UMLS CUI [1,3]
    C0205473
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    Similar models

    Eligibility HIV Infections NCT00192621

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age >18
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    be able to provide written consent to perform in the trial.
    boolean
    C0021430 (UMLS CUI [1])
    HIV antibody negative | Human immunodeficiency virus DNA Negative
    Item
    hiv antibody negative and hiv dna negative at time of entry to the study.
    boolean
    C1142096 (UMLS CUI [1])
    C0486959 (UMLS CUI [2,1])
    C1513916 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Mental disorders Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited | Myocardial Ischemia
    Item
    any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
    boolean
    C0004936 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C3714565 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C0439801 (UMLS CUI [2,3])
    C0151744 (UMLS CUI [3])
    Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics
    Item
    history of type i or type ii diabetes mellitus or previous treatment with antidiabetic medication.
    boolean
    C0011854 (UMLS CUI [1])
    C0011860 (UMLS CUI [2])
    C0935929 (UMLS CUI [3])
    Testosterone | Estrogens | Growth Hormone | Glucocorticoids Oral | Anabolic steroids
    Item
    prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
    boolean
    C0039601 (UMLS CUI [1])
    C0014939 (UMLS CUI [2])
    C0037663 (UMLS CUI [3])
    C0017710 (UMLS CUI [4,1])
    C1527415 (UMLS CUI [4,2])
    C0002845 (UMLS CUI [5])
    Substance Use Disorders Study Subject Participation Status Limited
    Item
    alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
    boolean
    C0038586 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Post-Exposure Prophylaxis
    Item
    prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
    boolean
    C0599685 (UMLS CUI [1])
    C0033607 (UMLS CUI [2])
    C1373111 (UMLS CUI [3])
    C1373120 (UMLS CUI [4])
    C0599685 (UMLS CUI [5,1])
    C1517586 (UMLS CUI [5,2])
    C1275666 (UMLS CUI [6])
    C1443861 (UMLS CUI [7])
    Compound Containing Retinoids
    Item
    prior use of any retinoid-containing compound within the previous six months.
    boolean
    C1706082 (UMLS CUI [1,1])
    C0332256 (UMLS CUI [1,2])
    C0035339 (UMLS CUI [1,3])
    Blood Coagulation Disorders
    Item
    abnormal coagulation.
    boolean
    C0005779 (UMLS CUI [1])
    Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics
    Item
    previous allergic reaction or known allergy to local anaesthetic.
    boolean
    C1527304 (UMLS CUI [1,1])
    C0002934 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0002934 (UMLS CUI [2,2])
    Psychotropic Drugs
    Item
    previous use of psychotropic medications.
    boolean
    C0033978 (UMLS CUI [1])
    Pharmaceutical Preparations Affecting Protocol Compliance | drug metabolism Due to CYP3A4
    Item
    concomitant use of medications, including those metabolised by cyp3a4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    C0683140 (UMLS CUI [2,1])
    C0678226 (UMLS CUI [2,2])
    C1142644 (UMLS CUI [2,3])
    Blood Screening LABORATORY ABNORMALITIES Grade
    Item
    any grade-three laboratory abnormality recorded from screening bloods.
    boolean
    C1511226 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited
    Item
    any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
    boolean
    C1511226 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C0441800 (UMLS CUI [1,3])
    C0525058 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    Gastrointestinal Diseases Affecting drug absorption
    Item
    gastrointestinal disorders, which may affect drug absorption.
    boolean
    C0017178 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0678745 (UMLS CUI [1,3])
    screening examination Finding Study Subject Participation Status Limited
    Item
    any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
    boolean
    C0281974 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C0439801 (UMLS CUI [1,4])
    Pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Hepatitis B Evidence Serologic
    Item
    evidence of acute or chronic active hepatitis b virus infection by serology performed at baseline.
    boolean
    C0019163 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    C0205473 (UMLS CUI [1,3])
    Hepatitis C Evidence Serologic
    Item
    evidence of hepatitis c infection by serology performed at baseline.
    boolean
    C0019196 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    C0205473 (UMLS CUI [1,3])
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