ID

20569

Description

Effects of Anti-HIV Drugs on the Hepatitis C Virus (HCV) in Adults Infected With Both HCV and HIV; ODM derived from: https://clinicaltrials.gov/show/NCT00545558

Link

https://clinicaltrials.gov/show/NCT00545558

Keywords

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

March 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00545558

English

Eligibility Hepatitis C NCT00545558

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hcv-infected
Description

hepatitis c

Data type

boolean

Alias
UMLS CUI [1]
C1112419
hiv-infected
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
liver biopsy consistent with chronic hepatitis within 1 year of study entry.
Description

liver biopsy, chronic hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C0019189
art-naive or no art for at least 3 months prior to study entry
Description

antiretroviral therapy

Data type

boolean

Alias
UMLS CUI [1]
C1963724
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hemoglobin less than 9 g/dl.
Description

hb

Data type

boolean

Alias
UMLS CUI [1]
C0518015
hepatitis b virus infected or antibody to hepatitis b core antigen, alpha-1 antitrypsin deficiency, wilson's disease, hemochromatosis, autoimmune disorder, or other concurrent liver disease
Description

Hepatitis B | Antibody to hepatitis B core antigen | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Hemochromatosis | Autoimmune Diseases | Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0312631
UMLS CUI [3]
C0221757
UMLS CUI [4]
C0019202
UMLS CUI [5]
C0018995
UMLS CUI [6]
C0004364
UMLS CUI [7]
C0023895
decompensated liver disease evidenced by active or history of encephalopathy, ascites, or variceal bleeding; prothrombin time (pt) greater than 3 seconds above normal or international normalized ratio (inr) greater than 1.3 sec; platelet count less than 90,000 k/ul. participants with cirrhosis will not be excluded.
Description

Decompensated liver disease | Hepatic Encephalopathy | Ascites | Bleeding varices | Prothrombin time assay | International Normalized Ratio | Platelet Count measurement | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0019151
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0333106
UMLS CUI [5]
C0033707
UMLS CUI [6]
C0525032
UMLS CUI [7]
C0032181
UMLS CUI [8]
C0023890
active thyroid disease. participants on thyroid replacement therapy with normal thyroid-stimulating hormone are not excluded.
Description

Thyroid Diseases; Active | Thyroid hormone replacement therapy; Serum TSH level normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C2242640
UMLS CUI [2,2]
C0580433
chronic kidney insufficiency, defined as creatinine clearance of greater than approximately 50 ml/min
Description

creatinine clearance, chronic kidney insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0403447
life-threatening disease processes other than hiv or hcv that could interfere with participation in the study
Description

Severe (severity modifier); Comorbidity | Limited (extensiveness); Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0009488
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C0525058
any condition that, in the opinion of the investigator, may interfere with completion of the study regimen. this includes severe psychiatric disorders, or active alcohol or recreational drug abuse
Description

Comorbidity | Limited (extensiveness); Protocol Compliance | Mental disorders | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C0525058
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0038586
use of systemic corticosteroids or immunomodulatory drugs within 1 month prior to study entry
Description

steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C1527392
current or prior successful interferon treatment
Description

interferon treatment

Data type

boolean

Alias
UMLS CUI [1]
C0279030
pregnancy or breastfeeding.
Description

pregnancy, breastfeeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
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Similar models

Eligibility Hepatitis C NCT00545558

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
hepatitis c
Item
hcv-infected
boolean
C1112419 (UMLS CUI [1])
hiv
Item
hiv-infected
boolean
C0019682 (UMLS CUI [1])
liver biopsy, chronic hepatitis
Item
liver biopsy consistent with chronic hepatitis within 1 year of study entry.
boolean
C0193388 (UMLS CUI [1])
C0019189 (UMLS CUI [2])
antiretroviral therapy
Item
art-naive or no art for at least 3 months prior to study entry
boolean
C1963724 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hb
Item
hemoglobin less than 9 g/dl.
boolean
C0518015 (UMLS CUI [1])
Hepatitis B | Antibody to hepatitis B core antigen | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Hemochromatosis | Autoimmune Diseases | Liver diseases
Item
hepatitis b virus infected or antibody to hepatitis b core antigen, alpha-1 antitrypsin deficiency, wilson's disease, hemochromatosis, autoimmune disorder, or other concurrent liver disease
boolean
C0019163 (UMLS CUI [1])
C0312631 (UMLS CUI [2])
C0221757 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0018995 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
Decompensated liver disease | Hepatic Encephalopathy | Ascites | Bleeding varices | Prothrombin time assay | International Normalized Ratio | Platelet Count measurement | Liver Cirrhosis
Item
decompensated liver disease evidenced by active or history of encephalopathy, ascites, or variceal bleeding; prothrombin time (pt) greater than 3 seconds above normal or international normalized ratio (inr) greater than 1.3 sec; platelet count less than 90,000 k/ul. participants with cirrhosis will not be excluded.
boolean
C4075847 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0033707 (UMLS CUI [5])
C0525032 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
C0023890 (UMLS CUI [8])
Thyroid Diseases; Active | Thyroid hormone replacement therapy; Serum TSH level normal
Item
active thyroid disease. participants on thyroid replacement therapy with normal thyroid-stimulating hormone are not excluded.
boolean
C0040128 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C2242640 (UMLS CUI [2,1])
C0580433 (UMLS CUI [2,2])
creatinine clearance, chronic kidney insufficiency
Item
chronic kidney insufficiency, defined as creatinine clearance of greater than approximately 50 ml/min
boolean
C0373595 (UMLS CUI [1])
C0403447 (UMLS CUI [2])
Severe (severity modifier); Comorbidity | Limited (extensiveness); Protocol Compliance
Item
life-threatening disease processes other than hiv or hcv that could interfere with participation in the study
boolean
C0205082 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0439801 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
Comorbidity | Limited (extensiveness); Protocol Compliance | Mental disorders | Substance Use Disorders
Item
any condition that, in the opinion of the investigator, may interfere with completion of the study regimen. this includes severe psychiatric disorders, or active alcohol or recreational drug abuse
boolean
C0009488 (UMLS CUI [1])
C0439801 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
steroid therapy
Item
use of systemic corticosteroids or immunomodulatory drugs within 1 month prior to study entry
boolean
C0149783 (UMLS CUI [1])
C1527392 (UMLS CUI [2])
interferon treatment
Item
current or prior successful interferon treatment
boolean
C0279030 (UMLS CUI [1])
pregnancy, breastfeeding
Item
pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
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