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])
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])