0 Avaliações
ID

42558

Descrição

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001); ODM derived from: https://clinicaltrials.gov/show/NCT00192660

Link

https://clinicaltrials.gov/show/NCT00192660

Palavras-chave

Versões (2)
  1. 24/09/2016 24/09/2016 -
  2. 02/09/2021 02/09/2021 -
Transferido a

2 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility HIV-Associated Lipodystrophy Syndrome NCT00192660

    Inglês

    Eligibility HIV-Associated Lipodystrophy Syndrome NCT00192660

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age >18.
    Descrição

    Age

    Tipo de dados

    boolean

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

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    hiv antibody positive at time of entry to the study.
    Descrição

    HIV antibody positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0920548
    specific to hiv infection and metabolic abnormalities protocol 1 (hama) part a only:
    Descrição

    HIV Infections | Abnormality of metabolism | Clinical Trial Part

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C4021768
    UMLS CUI [3,1]
    C0008976
    UMLS CUI [3,2]
    C0449719
    be naive to antiretroviral medication.
    Descrição

    Therapy naive Anti-Retroviral Agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0919936
    UMLS CUI [1,2]
    C0599685
    specific to hama part b only:
    Descrição

    HIV Infections | Abnormality of metabolism | Clinical Trial Part

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C4021768
    UMLS CUI [3,1]
    C0008976
    UMLS CUI [3,2]
    C0449719
    have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
    Descrição

    Anti-Retroviral Agents Exposure to Duration Total Minimum

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0599685
    UMLS CUI [1,2]
    C0332157
    UMLS CUI [1,3]
    C0449238
    UMLS CUI [1,4]
    C0439810
    UMLS CUI [1,5]
    C1524031
    have had a minimum of 48 weeks interval since completion of hama part a.
    Descrição

    Interval Since Clinical Trial Part Completion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1272706
    UMLS CUI [1,2]
    C1711239
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0449719
    UMLS CUI [1,5]
    C0205197
    Exclusion Criteria
    Descrição

    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.
    Descrição

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

    Tipo de dados

    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
    prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
    Descrição

    Growth Hormone | Glucocorticoids | Anabolic steroids

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0037663
    UMLS CUI [2]
    C0017710
    UMLS CUI [3]
    C0002845
    prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
    Descrição

    Testosterone Dose Very high | Estrogen Replacement Therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0039601
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0442804
    UMLS CUI [2]
    C0014935
    alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
    Descrição

    Substance Use Disorders Study Subject Participation Status Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0038586
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801
    prior use of any retinoid-containing compound within the previous six months.
    Descrição

    Compound Containing Retinoids

    Tipo de dados

    boolean

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

    Blood Coagulation Disorders

    Tipo de dados

    boolean

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

    Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0002934
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0002934
    previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
    Descrição

    Pharmaceutical Preparations Affecting Protocol Compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0525058
    any grade-three 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.
    Descrição

    Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited

    Tipo de dados

    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
    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.
    Descrição

    screening examination Finding Study Subject Participation Status Limited

    Tipo de dados

    boolean

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

    Pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    specific to hama part a only:
    Descrição

    HIV Infections | Abnormality of metabolism | Clinical Trial Part

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C4021768
    UMLS CUI [3,1]
    C0008976
    UMLS CUI [3,2]
    C0449719
    prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
    Descrição

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

    Tipo de dados

    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]
    C1963724
    UMLS CUI [8]
    C1443861
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    Similar models

    Eligibility HIV-Associated Lipodystrophy Syndrome NCT00192660

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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 positive
    Item
    hiv antibody positive at time of entry to the study.
    boolean
    C0920548 (UMLS CUI [1])
    HIV Infections | Abnormality of metabolism | Clinical Trial Part
    Item
    specific to hiv infection and metabolic abnormalities protocol 1 (hama) part a only:
    boolean
    C0019693 (UMLS CUI [1])
    C4021768 (UMLS CUI [2])
    C0008976 (UMLS CUI [3,1])
    C0449719 (UMLS CUI [3,2])
    Therapy naive Anti-Retroviral Agents
    Item
    be naive to antiretroviral medication.
    boolean
    C0919936 (UMLS CUI [1,1])
    C0599685 (UMLS CUI [1,2])
    HIV Infections | Abnormality of metabolism | Clinical Trial Part
    Item
    specific to hama part b only:
    boolean
    C0019693 (UMLS CUI [1])
    C4021768 (UMLS CUI [2])
    C0008976 (UMLS CUI [3,1])
    C0449719 (UMLS CUI [3,2])
    Anti-Retroviral Agents Exposure to Duration Total Minimum
    Item
    have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
    boolean
    C0599685 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    C0439810 (UMLS CUI [1,4])
    C1524031 (UMLS CUI [1,5])
    Interval Since Clinical Trial Part Completion
    Item
    have had a minimum of 48 weeks interval since completion of hama part a.
    boolean
    C1272706 (UMLS CUI [1,1])
    C1711239 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0449719 (UMLS CUI [1,4])
    C0205197 (UMLS CUI [1,5])
    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])
    Growth Hormone | Glucocorticoids | Anabolic steroids
    Item
    prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
    boolean
    C0037663 (UMLS CUI [1])
    C0017710 (UMLS CUI [2])
    C0002845 (UMLS CUI [3])
    Testosterone Dose Very high | Estrogen Replacement Therapy
    Item
    prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
    boolean
    C0039601 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0442804 (UMLS CUI [1,3])
    C0014935 (UMLS CUI [2])
    Substance Use Disorders Study Subject Participation Status Limited
    Item
    alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
    boolean
    C0038586 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    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])
    Pharmaceutical Preparations Affecting Protocol Compliance
    Item
    previous or concomitant use of medications, 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])
    Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited
    Item
    any grade-three 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])
    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])
    HIV Infections | Abnormality of metabolism | Clinical Trial Part
    Item
    specific to hama part a only:
    boolean
    C0019693 (UMLS CUI [1])
    C4021768 (UMLS CUI [2])
    C0008976 (UMLS CUI [3,1])
    C0449719 (UMLS CUI [3,2])
    Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Antiretroviral therapy | 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). entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
    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])
    C1963724 (UMLS CUI [7])
    C1443861 (UMLS CUI [8])
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