ID

20954

Description

Study of Hepatitis C Virus (HCV) Viral Kinetics in HIV/HCV and HCV Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00703560

Link

https://clinicaltrials.gov/show/NCT00703560

Keywords

Versions (1)
  1. 3/30/17 3/30/17 -
Uploaded on

March 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00703560

English

Eligibility Hepatitis C NCT00703560

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hcv infection, as documented by the presence of circulating levels of hcv rna by any rt-pcr or bdna assay performed by a laboratory with a clia certification or its equivalent within 52 weeks prior to study entry.
Description

Hepatitis C | HCV viral load Levels Circulating | Reverse Transcriptase Polymerase Chain Reaction | Branched DNA Assay

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1868902
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0175630
UMLS CUI [3]
C0599161
UMLS CUI [4]
C0887812
2. hcv rna >1000 iu/ml.
Description

HCV viral load Levels

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C0441889
3. documented genotype 1 performed by any clia certified lab.
Description

Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C1148363
4. men and women age 18 to 65 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. ability and willingness of subject or legal guardian/representative to give written informed consent.
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
6. female study volunteers of reproductive potential must be willing to use two methods of birth control in order to prevent pregnancy while on ifn/rbv.
Description

Childbearing Potential Contraceptive methods Quantity | Interferon | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0035525
for hiv infected patients:
Description

Patients HIV Infection Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0019693
UMLS CUI [1,3]
C1512693
1. hiv-1 infection, as documented by any licensed elisa test kit and confirmed by western blot at any time prior to study entry. hiv-1 culture, hiv-1 antigen, plasma hiv-1 rna, or a second antibody test by a method other than elisa is acceptable as an alternative confirmatory test.
Description

HIV-1 Infection Enzyme-Linked Immunosorbent Assay | HIV-1 Western blot assay | HIV-1 culture | HIV-1 antigen | Human immunodeficiency virus 1 RNA Plasma | Antibody test second

Data type

boolean

Alias
UMLS CUI [1,1]
C0019704
UMLS CUI [1,2]
C3714514
UMLS CUI [1,3]
C0014441
UMLS CUI [2]
C0201392
UMLS CUI [3,1]
C0019704
UMLS CUI [3,2]
C0430400
UMLS CUI [4]
C0369498
UMLS CUI [5,1]
C0369499
UMLS CUI [5,2]
C0032105
UMLS CUI [6,1]
C0580327
UMLS CUI [6,2]
C0205436
2. cd4+ cell count ³ 300 cells/mm3 within the prior 12 weeks at a clia certified lab or its equivalent.
Description

CD4 Count

Data type

boolean

Alias
UMLS CUI [1]
C0243009
3. subject may be haart naïve, but if on haart should be on a stable regimen for 12 weeks the haart regimen cannot include didanosine (videx). interaction with ribavirin and didanosine has led to fatal hyperlactatemia in a few patients.
Description

Highly Active Antiretroviral Therapy naive | Highly Active Antiretroviral Therapy Stable | Didanosine | Videx | Ribavirin | Hyperlactatemia Fatal

Data type

boolean

Alias
UMLS CUI [1,1]
C0887947
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0887947
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0012133
UMLS CUI [4]
C0592249
UMLS CUI [5]
C0035525
UMLS CUI [6,1]
C0795692
UMLS CUI [6,2]
C1302234
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. unwilling to be admitted for 48 hours for serial blood draws for virology studies.
Description

Blood draw Series Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0205549
UMLS CUI [1,3]
C0558080
2. hepatitis b surface antigen (hbsag) positivity.
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
3. prior ifn -based therapy.
Description

Interferon

Data type

boolean

Alias
UMLS CUI [1]
C3652465
additional exclusion for hiv-infected:
Description

Patients HIV Infection Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0019693
UMLS CUI [1,3]
C0680251
1. current symptomatic hiv disease (i.e., aids-defining illnesses).
Description

HIV Infection Symptomatic | AIDS defining illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0740830
2. haart regimen that contains videx (didanosine). subject may previously have been on didanosine but if on a new haart regimen should be on the regimen for 12 weeks.
Description

Antiretroviral Therapy, Highly Active | Videx | Didanosine

Data type

boolean

Alias
UMLS CUI [1]
C0887947
UMLS CUI [2]
C0592249
UMLS CUI [3]
C0012133
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Similar models

Eligibility Hepatitis C NCT00703560

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C | HCV viral load Levels Circulating | Reverse Transcriptase Polymerase Chain Reaction | Branched DNA Assay
Item
1. hcv infection, as documented by the presence of circulating levels of hcv rna by any rt-pcr or bdna assay performed by a laboratory with a clia certification or its equivalent within 52 weeks prior to study entry.
boolean
C0019196 (UMLS CUI [1])
C1868902 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0175630 (UMLS CUI [2,3])
C0599161 (UMLS CUI [3])
C0887812 (UMLS CUI [4])
HCV viral load Levels
Item
2. hcv rna >1000 iu/ml.
boolean
C1868902 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Hepatitis C virus genotype
Item
3. documented genotype 1 performed by any clia certified lab.
boolean
C1148363 (UMLS CUI [1])
Age
Item
4. men and women age 18 to 65 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardian
Item
5. ability and willingness of subject or legal guardian/representative to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Quantity | Interferon | Ribavirin
Item
6. female study volunteers of reproductive potential must be willing to use two methods of birth control in order to prevent pregnancy while on ifn/rbv.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Patients HIV Infection Inclusion criteria
Item
for hiv infected patients:
boolean
C0030705 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
HIV-1 Infection Enzyme-Linked Immunosorbent Assay | HIV-1 Western blot assay | HIV-1 culture | HIV-1 antigen | Human immunodeficiency virus 1 RNA Plasma | Antibody test second
Item
1. hiv-1 infection, as documented by any licensed elisa test kit and confirmed by western blot at any time prior to study entry. hiv-1 culture, hiv-1 antigen, plasma hiv-1 rna, or a second antibody test by a method other than elisa is acceptable as an alternative confirmatory test.
boolean
C0019704 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0014441 (UMLS CUI [1,3])
C0201392 (UMLS CUI [2])
C0019704 (UMLS CUI [3,1])
C0430400 (UMLS CUI [3,2])
C0369498 (UMLS CUI [4])
C0369499 (UMLS CUI [5,1])
C0032105 (UMLS CUI [5,2])
C0580327 (UMLS CUI [6,1])
C0205436 (UMLS CUI [6,2])
CD4 Count
Item
2. cd4+ cell count ³ 300 cells/mm3 within the prior 12 weeks at a clia certified lab or its equivalent.
boolean
C0243009 (UMLS CUI [1])
Highly Active Antiretroviral Therapy naive | Highly Active Antiretroviral Therapy Stable | Didanosine | Videx | Ribavirin | Hyperlactatemia Fatal
Item
3. subject may be haart naïve, but if on haart should be on a stable regimen for 12 weeks the haart regimen cannot include didanosine (videx). interaction with ribavirin and didanosine has led to fatal hyperlactatemia in a few patients.
boolean
C0887947 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0887947 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0012133 (UMLS CUI [3])
C0592249 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C0795692 (UMLS CUI [6,1])
C1302234 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Blood draw Series Unwilling
Item
1. unwilling to be admitted for 48 hours for serial blood draws for virology studies.
boolean
C0005834 (UMLS CUI [1,1])
C0205549 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Hepatitis B surface antigen positive
Item
2. hepatitis b surface antigen (hbsag) positivity.
boolean
C0149709 (UMLS CUI [1])
Interferon
Item
3. prior ifn -based therapy.
boolean
C3652465 (UMLS CUI [1])
Patients HIV Infection Exclusion Criteria
Item
additional exclusion for hiv-infected:
boolean
C0030705 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
HIV Infection Symptomatic | AIDS defining illness
Item
1. current symptomatic hiv disease (i.e., aids-defining illnesses).
boolean
C0019693 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0740830 (UMLS CUI [2])
Antiretroviral Therapy, Highly Active | Videx | Didanosine
Item
2. haart regimen that contains videx (didanosine). subject may previously have been on didanosine but if on a new haart regimen should be on the regimen for 12 weeks.
boolean
C0887947 (UMLS CUI [1])
C0592249 (UMLS CUI [2])
C0012133 (UMLS CUI [3])
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