ID

39639

Descripción

Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01427504

Link

https://clinicaltrials.gov/show/NCT01427504

Palabras clave

Versiones (1)
  1. 7/2/20 7/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01427504

Inglés

Eligibility Hepatitis C NCT01427504

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 18-60 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
absence of hiv-1 and hcv antibodies at screening
Descripción

Human immunodeficiency virus type 1 antibody Absent | Hepatitis C Antibodies Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0369497
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0332197
ability and willingness to give written informed consent before the first trial-related activity
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Descripción

Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements.
Descripción

Substance Use Disorder Interferes with Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
participation in any investigation drug study within 30 days prior to study.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results.
Descripción

Gastrointestinal Disease | Gastrointestinal Disease chronic | Cardiovascular Disease | Chronic disease of cardiovascular system | Nervous system disorder | Chronic nervous system disorder | Mental disorder | Chronic mental disorder | Metabolic Disease | Chronic metabolic disorder | Kidney Disease | Chronic Kidney Disease | Liver disease | Chronic liver disease | Respiration Disorders | Chronic disease of respiratory system | Inflammatory disorder | Chronic inflammatory disorder | Communicable Disease | Chronic infectious disease | Malignant Neoplasms Requirement Pharmacotherapy | Disease Affecting Study Subject Participation Status | Disease Affecting Safety | Disease Affecting Integrity Research results

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0007222
UMLS CUI [4]
C1290380
UMLS CUI [5]
C0027765
UMLS CUI [6]
C1290882
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0870281
UMLS CUI [9]
C0025517
UMLS CUI [10]
C1263722
UMLS CUI [11]
C0022658
UMLS CUI [12]
C1561643
UMLS CUI [13]
C0023895
UMLS CUI [14]
C0341439
UMLS CUI [15]
C0035204
UMLS CUI [16]
C0264220
UMLS CUI [17]
C1290884
UMLS CUI [18]
C1290886
UMLS CUI [19]
C0009450
UMLS CUI [20]
C0151317
UMLS CUI [21,1]
C0006826
UMLS CUI [21,2]
C1514873
UMLS CUI [21,3]
C0013216
UMLS CUI [22,1]
C0012634
UMLS CUI [22,2]
C0392760
UMLS CUI [22,3]
C2348568
UMLS CUI [23,1]
C0012634
UMLS CUI [23,2]
C0392760
UMLS CUI [23,3]
C0036043
UMLS CUI [24,1]
C0012634
UMLS CUI [24,2]
C0392760
UMLS CUI [24,3]
C1947912
UMLS CUI [24,4]
C0683954
use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). concomitant medications other than those listed above must have been discontinued at least 14 days before study entry.
Descripción

Investigational New Drugs | Prescription Drugs | Drugs, Non-Prescription | Dietary Supplements | Exception Aspirin | Exception Acetaminophen | Exception Multivitamins times/day | Exception Mineral supplements | Exception Hormonal Oral Contraceptives | Drospirenone Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0304227
UMLS CUI [3]
C0013231
UMLS CUI [4]
C0242295
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0004057
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0000970
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0301532
UMLS CUI [7,3]
C0439511
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0556112
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0009907
UMLS CUI [10,1]
C0043822
UMLS CUI [10,2]
C0332196
currently active dermatitis or urticaria or diagnosis of eczema or psoriasis.
Descripción

Dermatitis | Urticaria | Eczema | Psoriasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011603
UMLS CUI [2]
C0042109
UMLS CUI [3]
C0013595
UMLS CUI [4]
C0033860
history of significant drug allergy (i.e., anaphylaxis and/or angioedema)
Descripción

Drug Allergy | Anaphylaxis | Angioedema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0002792
UMLS CUI [3]
C0002994
subjects with the following laboratory abnormalities at screening as defined by the 2004 division of aids table for grading the severity of adult and pediatric adverse events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (>1.1 x upper limit of laboratory normal range (uln); hemoglobin grade 1 or greater (≤ 10.9 g/dl); platelet count grade 1 or greater (≤ 124.999 x 109/l); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/l); aspartate aminotransferase (ast) or alanine aminotransferase (alt) grade 1 or greater (≥ 1.25 x uln); total bilirubin grade 1 or greater (≥ 1.1 x uln), any other laboratory abnormality of grade 2 or above
Descripción

Laboratory test result abnormal | Serum creatinine raised Grade | Hemoglobin measurement Grade | Platelet Count measurement Grade | Absolute neutrophil count Grade | Aspartate aminotransferase increased Grade | Alanine aminotransferase increased Grade | Elevated total bilirubin Grade | Laboratory test result abnormal Grade

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0700225
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0518015
UMLS CUI [3,2]
C0441800
UMLS CUI [4,1]
C0032181
UMLS CUI [4,2]
C0441800
UMLS CUI [5,1]
C0948762
UMLS CUI [5,2]
C0441800
UMLS CUI [6,1]
C0151904
UMLS CUI [6,2]
C0441800
UMLS CUI [7,1]
C0151905
UMLS CUI [7,2]
C0441800
UMLS CUI [8,1]
C0741494
UMLS CUI [8,2]
C0441800
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C0441800
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Similar models

Eligibility Hepatitis C NCT01427504

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 18-60 years
boolean
C0001779 (UMLS CUI [1])
Human immunodeficiency virus type 1 antibody Absent | Hepatitis C Antibodies Absent
Item
absence of hiv-1 and hcv antibodies at screening
boolean
C0369497 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0166049 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
ability and willingness to give written informed consent before the first trial-related activity
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Substance Use Disorder Interferes with Protocol Compliance
Item
active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements.
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any investigation drug study within 30 days prior to study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Gastrointestinal Disease | Gastrointestinal Disease chronic | Cardiovascular Disease | Chronic disease of cardiovascular system | Nervous system disorder | Chronic nervous system disorder | Mental disorder | Chronic mental disorder | Metabolic Disease | Chronic metabolic disorder | Kidney Disease | Chronic Kidney Disease | Liver disease | Chronic liver disease | Respiration Disorders | Chronic disease of respiratory system | Inflammatory disorder | Chronic inflammatory disorder | Communicable Disease | Chronic infectious disease | Malignant Neoplasms Requirement Pharmacotherapy | Disease Affecting Study Subject Participation Status | Disease Affecting Safety | Disease Affecting Integrity Research results
Item
currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results.
boolean
C0017178 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C1290380 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C1290882 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0870281 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C1263722 (UMLS CUI [10])
C0022658 (UMLS CUI [11])
C1561643 (UMLS CUI [12])
C0023895 (UMLS CUI [13])
C0341439 (UMLS CUI [14])
C0035204 (UMLS CUI [15])
C0264220 (UMLS CUI [16])
C1290884 (UMLS CUI [17])
C1290886 (UMLS CUI [18])
C0009450 (UMLS CUI [19])
C0151317 (UMLS CUI [20])
C0006826 (UMLS CUI [21,1])
C1514873 (UMLS CUI [21,2])
C0013216 (UMLS CUI [21,3])
C0012634 (UMLS CUI [22,1])
C0392760 (UMLS CUI [22,2])
C2348568 (UMLS CUI [22,3])
C0012634 (UMLS CUI [23,1])
C0392760 (UMLS CUI [23,2])
C0036043 (UMLS CUI [23,3])
C0012634 (UMLS CUI [24,1])
C0392760 (UMLS CUI [24,2])
C1947912 (UMLS CUI [24,3])
C0683954 (UMLS CUI [24,4])
Investigational New Drugs | Prescription Drugs | Drugs, Non-Prescription | Dietary Supplements | Exception Aspirin | Exception Acetaminophen | Exception Multivitamins times/day | Exception Mineral supplements | Exception Hormonal Oral Contraceptives | Drospirenone Excluded
Item
use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). concomitant medications other than those listed above must have been discontinued at least 14 days before study entry.
boolean
C0013230 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0013231 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0004057 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0000970 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0301532 (UMLS CUI [7,2])
C0439511 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0556112 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0009907 (UMLS CUI [9,2])
C0043822 (UMLS CUI [10,1])
C0332196 (UMLS CUI [10,2])
Dermatitis | Urticaria | Eczema | Psoriasis
Item
currently active dermatitis or urticaria or diagnosis of eczema or psoriasis.
boolean
C0011603 (UMLS CUI [1])
C0042109 (UMLS CUI [2])
C0013595 (UMLS CUI [3])
C0033860 (UMLS CUI [4])
Drug Allergy | Anaphylaxis | Angioedema
Item
history of significant drug allergy (i.e., anaphylaxis and/or angioedema)
boolean
C0013182 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C0002994 (UMLS CUI [3])
Laboratory test result abnormal | Serum creatinine raised Grade | Hemoglobin measurement Grade | Platelet Count measurement Grade | Absolute neutrophil count Grade | Aspartate aminotransferase increased Grade | Alanine aminotransferase increased Grade | Elevated total bilirubin Grade | Laboratory test result abnormal Grade
Item
subjects with the following laboratory abnormalities at screening as defined by the 2004 division of aids table for grading the severity of adult and pediatric adverse events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (>1.1 x upper limit of laboratory normal range (uln); hemoglobin grade 1 or greater (≤ 10.9 g/dl); platelet count grade 1 or greater (≤ 124.999 x 109/l); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/l); aspartate aminotransferase (ast) or alanine aminotransferase (alt) grade 1 or greater (≥ 1.25 x uln); total bilirubin grade 1 or greater (≥ 1.1 x uln), any other laboratory abnormality of grade 2 or above
boolean
C0438215 (UMLS CUI [1])
C0700225 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0518015 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0032181 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0948762 (UMLS CUI [5,1])
C0441800 (UMLS CUI [5,2])
C0151904 (UMLS CUI [6,1])
C0441800 (UMLS CUI [6,2])
C0151905 (UMLS CUI [7,1])
C0441800 (UMLS CUI [7,2])
C0741494 (UMLS CUI [8,1])
C0441800 (UMLS CUI [8,2])
C0438215 (UMLS CUI [9,1])
C0441800 (UMLS CUI [9,2])
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