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. 6/2/20 6/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2020

DOI

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License

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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