Informed Consent
Item
1. provision of written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Hepatitis C virus genotype 1 Infection
Item
2. hcv genotype 1 infection
boolean
C3532919 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
3. quantifiable hcv rna at screening and baseline (>10,000 iu/ml)
boolean
C1272251 (UMLS CUI [1])
Hepatitis C Duration
Item
4. recent hepatitis c infection with an estimated duration of infection >6 months and ≤
boolean
C0019196 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis C Antibodies | Hepatitis C RNA positive | Hepatitis C antibody negative | Hepatitis C RNA negative | Hepatitis | Jaundice | Alanine aminotransferase increased
Item
18 months defined as a) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) documented anti-hcv antibody negative or hcv rna negative within the 24 months prior to anti-hcv antibody positive result or b) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the 12 months prior to first positive hcv antibody or hcv rna with no other cause of acute hepatitis identifiable
boolean
C0166049 (UMLS CUI [1])
C0855842 (UMLS CUI [2])
C0853904 (UMLS CUI [3])
C0855841 (UMLS CUI [4])
C0019158 (UMLS CUI [5])
C2010848 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
Compensated liver disease Child-Pugh Classification
Item
5. compensated liver disease (child-pugh a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Pregnancy test negative
Item
6. negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
boolean
C0427780 (UMLS CUI [1])
Childbearing Potential Sexually active Contraceptive methods Quantity | Gender Without Vasectomy | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Contraceptive methods Except Hormonal contraception
Item
7. if heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after rbv therapy has ended. note: hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. as of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0042387 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0700589 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C2985296 (UMLS CUI [5,3])
Patient's condition stable Physical Examination | Patient's condition stable Medical History | Patient's condition stable Vital signs
Item
8. subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
boolean
C1282982 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1282982 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1282982 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
Language skills English | Informed Consent | Patient interview
Item
9. adequate english to provide written, informed consent and to provide reliable responses to the study interview
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0683518 (UMLS CUI [3])
Inclusion criteria Patients HIV Seropositivity
Item
additional inclusion criteria for hiv positive individuals
boolean
C1512693 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,3])
HIV Infection Duration
Item
confirmed hiv infection > 6 months duration
boolean
C0019693 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
CD4 Count determination | HIV viral load | Antiretroviral therapy Stable
Item
cd4 > 200 cells/mm3 and hiv < 50 c/ml on stable art at least 3 months prior to treatment
boolean
C0243009 (UMLS CUI [1])
C1168369 (UMLS CUI [2])
C1963724 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
CD4 Count determination | HIV viral load | Antiretroviral therapy Absent
Item
cd4 >= 500 cells/mm3 and hiv vl < 100,000 not on art
boolean
C0243009 (UMLS CUI [1])
C1168369 (UMLS CUI [2])
C1963724 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Antiretroviral therapy | Combined Modality Therapy | Tenofovir | Lamivudine | emtricitabine | efavirenz | abacavir | raltegravir | etravirine | Rilpivirine | Atazanavir+Ritonavir
Item
if on art must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( tdf), lamivudine ( 3tc), emtricitabine (ftc), efavirenz (efv), abacavir (abc), raltegravir (ral), etravirine (etv), rilpivirine (ril), ritonavir boosted atazanavir (r/atz) * combination must be supported by current hiv treatment guidelines
boolean
C1963724 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0384228 (UMLS CUI [3])
C0209738 (UMLS CUI [4])
C0909839 (UMLS CUI [5])
C0674428 (UMLS CUI [6])
C0663655 (UMLS CUI [7])
C1871526 (UMLS CUI [8])
C1456409 (UMLS CUI [9])
C1566826 (UMLS CUI [10])
C1977391 (UMLS CUI [11])
Study Subject Participation Status | Follow-up Unlikely | Collection of blood specimen Unwilling
Item
individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
boolean
C2348568 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Injecting drug user
Item
current injecting drug use (any injecting within previous 4 weeks)
boolean
C0556025 (UMLS CUI [1])
PEGINTERFERON | Ribavirin | telaprevir
Item
standard exclusions to peg-interferon (peg-ifn), ribavirin (rbv) and telaprevir (tpv) therapy
boolean
C0982327 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C1876229 (UMLS CUI [3])