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ID

40908

Description

Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection; ODM derived from: https://clinicaltrials.gov/show/NCT01182298

Link

https://clinicaltrials.gov/show/NCT01182298

Keywords

Versions (1)
  1. 02/06/2020 02/06/2020 -
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See clinicaltrials.gov

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2 juin 2020

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Creative Commons BY 4.0
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    Eligibility Hepatitis C NCT01182298

    English

    Eligibility Hepatitis C NCT01182298

    1 forms  
    Criteria
    Description

    Criteria

    a subject must satisfy all of the following criteria to be eligible to participate in this study:
    Description

    Inclusion criteria All Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0444868
    UMLS CUI [1,3]
    C1550543
    1. latino ethnicity. latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from spanish-speaking countries in south and central america, mexico, and the caribbean. both parents and all grandparents of the participant have to be latino, with spanish as the primary language. participants have to be white; native aboriginal indians, asians, and blacks will be excluded.
    Description

    Latino | Primary Language Spanish

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0086528
    UMLS CUI [2,1]
    C1717991
    UMLS CUI [2,2]
    C0037750
    2. age greater than or equal to 18 years.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. documentation of hepatitis c infection by demonstration of a positive test for hepatitis c antibody and hcv rna level of greater than or equal to 2,000 iu/ml.
    Description

    Hepatitis C | Hepatitis C antibody positive | Hepatitis C virus RNA assay

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019196
    UMLS CUI [2]
    C0281863
    UMLS CUI [3]
    C1272251
    4. documentation of hiv-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a western blot or by hiv polymerase chain reaction positive.
    Description

    HIV-1 infection Enzyme-Linked Immunosorbent Assay | HIV-1 infection Western Blot | HIV Polymerase chain reaction positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2363741
    UMLS CUI [1,2]
    C0014441
    UMLS CUI [2,1]
    C2363741
    UMLS CUI [2,2]
    C0949466
    UMLS CUI [3,1]
    C0019682
    UMLS CUI [3,2]
    C3888499
    5. participants with hiv: cd4+ cell counts greater than or equal to 100 cells/mm(3) or cd4+ cell percentage greater than or equal to 14%.
    Description

    HIV Infection | CD4 Expressing Cell Count | CD4+ cell Percentage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C3541261
    UMLS CUI [3,1]
    C3251824
    UMLS CUI [3,2]
    C0439165
    6. ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies.
    Description

    Informed Consent | Protocol Compliance | Storage Blood specimen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0525058
    UMLS CUI [3,1]
    C1698986
    UMLS CUI [3,2]
    C0178913
    7. participants must have a primary care physician managing medical problems.
    Description

    Primary Care Physician Disease Management

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033131
    UMLS CUI [1,2]
    C0376636
    8. for hiv infected participants, care provided by a primary physician must be consistent with the current dhhs guidelines. for those on therapy, haart will be provided by their physician.
    Description

    HIV Infection | Care Primary physician | Antiretroviral Therapy, Highly Active

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2,1]
    C1947933
    UMLS CUI [2,2]
    C1508823
    UMLS CUI [3]
    C0887947
    9. willing to undergo genetic testing
    Description

    Genetic testing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0679560
    10. about to start hcv treatment (with or without direct acting agents daas)
    Description

    Therapy Hepatitis C | DIRECT ACTING ANTIVIRALS | DIRECT ACTING ANTIVIRALS Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0019196
    UMLS CUI [2]
    C3653501
    UMLS CUI [3,1]
    C3653501
    UMLS CUI [3,2]
    C0332197
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    a subject will be ineligible to participate in this study if any of the following criteria are met:
    Description

    Exclusion Criteria Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1550543
    1. unable to comply with research study visits
    Description

    Compliance Research study Visit Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0681814
    UMLS CUI [1,3]
    C1512346
    UMLS CUI [1,4]
    C1299582
    2. have any condition that the investigator considers a contraindication to study participation.
    Description

    Condition Study Subject Participation Status Contraindicated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1444657
    3. pregnant or breastfeeding women.
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    4. patients with poor venous access
    Description

    Poor venous access

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0577866
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    Similar models

    Eligibility Hepatitis C NCT01182298

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion criteria All Fulfill
    Item
    a subject must satisfy all of the following criteria to be eligible to participate in this study:
    boolean
    C1512693 (UMLS CUI [1,1])
    C0444868 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    Latino | Primary Language Spanish
    Item
    1. latino ethnicity. latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from spanish-speaking countries in south and central america, mexico, and the caribbean. both parents and all grandparents of the participant have to be latino, with spanish as the primary language. participants have to be white; native aboriginal indians, asians, and blacks will be excluded.
    boolean
    C0086528 (UMLS CUI [1])
    C1717991 (UMLS CUI [2,1])
    C0037750 (UMLS CUI [2,2])
    Age
    Item
    2. age greater than or equal to 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    Hepatitis C | Hepatitis C antibody positive | Hepatitis C virus RNA assay
    Item
    3. documentation of hepatitis c infection by demonstration of a positive test for hepatitis c antibody and hcv rna level of greater than or equal to 2,000 iu/ml.
    boolean
    C0019196 (UMLS CUI [1])
    C0281863 (UMLS CUI [2])
    C1272251 (UMLS CUI [3])
    HIV-1 infection Enzyme-Linked Immunosorbent Assay | HIV-1 infection Western Blot | HIV Polymerase chain reaction positive
    Item
    4. documentation of hiv-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a western blot or by hiv polymerase chain reaction positive.
    boolean
    C2363741 (UMLS CUI [1,1])
    C0014441 (UMLS CUI [1,2])
    C2363741 (UMLS CUI [2,1])
    C0949466 (UMLS CUI [2,2])
    C0019682 (UMLS CUI [3,1])
    C3888499 (UMLS CUI [3,2])
    HIV Infection | CD4 Expressing Cell Count | CD4+ cell Percentage
    Item
    5. participants with hiv: cd4+ cell counts greater than or equal to 100 cells/mm(3) or cd4+ cell percentage greater than or equal to 14%.
    boolean
    C0019693 (UMLS CUI [1])
    C3541261 (UMLS CUI [2])
    C3251824 (UMLS CUI [3,1])
    C0439165 (UMLS CUI [3,2])
    Informed Consent | Protocol Compliance | Storage Blood specimen
    Item
    6. ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies.
    boolean
    C0021430 (UMLS CUI [1])
    C0525058 (UMLS CUI [2])
    C1698986 (UMLS CUI [3,1])
    C0178913 (UMLS CUI [3,2])
    Primary Care Physician Disease Management
    Item
    7. participants must have a primary care physician managing medical problems.
    boolean
    C0033131 (UMLS CUI [1,1])
    C0376636 (UMLS CUI [1,2])
    HIV Infection | Care Primary physician | Antiretroviral Therapy, Highly Active
    Item
    8. for hiv infected participants, care provided by a primary physician must be consistent with the current dhhs guidelines. for those on therapy, haart will be provided by their physician.
    boolean
    C0019693 (UMLS CUI [1])
    C1947933 (UMLS CUI [2,1])
    C1508823 (UMLS CUI [2,2])
    C0887947 (UMLS CUI [3])
    Genetic testing
    Item
    9. willing to undergo genetic testing
    boolean
    C0679560 (UMLS CUI [1])
    Therapy Hepatitis C | DIRECT ACTING ANTIVIRALS | DIRECT ACTING ANTIVIRALS Absent
    Item
    10. about to start hcv treatment (with or without direct acting agents daas)
    boolean
    C0087111 (UMLS CUI [1,1])
    C0019196 (UMLS CUI [1,2])
    C3653501 (UMLS CUI [2])
    C3653501 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion Criteria Fulfill
    Item
    a subject will be ineligible to participate in this study if any of the following criteria are met:
    boolean
    C0680251 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    Compliance Research study Visit Unable
    Item
    1. unable to comply with research study visits
    boolean
    C1321605 (UMLS CUI [1,1])
    C0681814 (UMLS CUI [1,2])
    C1512346 (UMLS CUI [1,3])
    C1299582 (UMLS CUI [1,4])
    Condition Study Subject Participation Status Contraindicated
    Item
    2. have any condition that the investigator considers a contraindication to study participation.
    boolean
    C0348080 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444657 (UMLS CUI [1,3])
    Pregnancy | Breast Feeding
    Item
    3. pregnant or breastfeeding women.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Poor venous access
    Item
    4. patients with poor venous access
    boolean
    C0577866 (UMLS CUI [1])
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