ID

39578

Description

Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT02220868

Link

https://clinicaltrials.gov/show/NCT02220868

Keywords

Versions (1)
  1. 1/31/20 1/31/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 31, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C Infection NCT02220868

English

Eligibility Hepatitis C Infection NCT02220868

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
chronic hcv genotype 1 infection
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
Description

Cobicistat and elvitegravir and emtricitabine and tenofovir

Data type

boolean

Alias
UMLS CUI [1]
C3499879
cd4 count >200 cells/mm3 at screening and no cd4 count <200 in previous 12 weeks
Description

CD4 Count

Data type

boolean

Alias
UMLS CUI [1]
C0243009
hiv rna pcr <50 copies/ml at screening and no hiv rna pcr > 200 copies/ml in previous 12 weeks
Description

Human Immunodeficiency Virus RNA copies/mL Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C4330330
UMLS CUI [1,2]
C1531853
UMLS CUI [1,3]
C0032520
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of integrase inhibitor resistance
Description

Integrase Inhibitor Resistance

Data type

boolean

Alias
UMLS CUI [1,1]
C0376601
UMLS CUI [1,2]
C1514892
history of integrase inhibitor failure
Description

Integrase Inhibitor Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0376601
UMLS CUI [1,2]
C0231174
absolute neutrophil counts under 1500/mm3 ( black/ african americans <1200/mm3
Description

Absolute neutrophil count | African Americans

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0085756
patients with cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
platelet count under 90,000 per cubic millimeter
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
previous treatment with a daa
Description

DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1]
C3653501
hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
afp>100 ng/ml
Description

Alpha one fetoprotein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201539
hepatitis b virus (hbsag positive)
Description

Hepatitis B Virus | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0019169
UMLS CUI [2]
C0149709
evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Description

Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
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Similar models

Eligibility Hepatitis C Infection NCT02220868

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
chronic hcv genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Cobicistat and elvitegravir and emtricitabine and tenofovir
Item
receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
boolean
C3499879 (UMLS CUI [1])
CD4 Count
Item
cd4 count >200 cells/mm3 at screening and no cd4 count <200 in previous 12 weeks
boolean
C0243009 (UMLS CUI [1])
Human Immunodeficiency Virus RNA copies/mL Polymerase Chain Reaction
Item
hiv rna pcr <50 copies/ml at screening and no hiv rna pcr > 200 copies/ml in previous 12 weeks
boolean
C4330330 (UMLS CUI [1,1])
C1531853 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Integrase Inhibitor Resistance
Item
history of integrase inhibitor resistance
boolean
C0376601 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
Integrase Inhibitor Failure
Item
history of integrase inhibitor failure
boolean
C0376601 (UMLS CUI [1,1])
C0231174 (UMLS CUI [1,2])
Absolute neutrophil count | African Americans
Item
absolute neutrophil counts under 1500/mm3 ( black/ african americans <1200/mm3
boolean
C0948762 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Liver Cirrhosis
Item
patients with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count under 90,000 per cubic millimeter
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
DIRECT ACTING ANTIVIRALS
Item
previous treatment with a daa
boolean
C3653501 (UMLS CUI [1])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alpha one fetoprotein measurement
Item
afp>100 ng/ml
boolean
C0201539 (UMLS CUI [1])
Hepatitis B Virus | Hepatitis B surface antigen positive
Item
hepatitis b virus (hbsag positive)
boolean
C0019169 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
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