ID

36077

Description

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT02404805

Link

https://clinicaltrials.gov/show/NCT02404805

Keywords

Versions (1)
  1. 4/14/19 4/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility HIV NCT02404805

English

Eligibility HIV NCT02404805

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT02404805
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

HIV-1 Absent | HCV Antibodies Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019704
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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Description

Breast Feeding

Data type

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
Description

Substance Use Disorder Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
participation in any investigational drug study within 30 days prior to study entry
Description

Study Subject Participation Status | Investigational New Drugs

Data type

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
Description

Gastrointestinal Diseases | Cardiovascular Diseases | Nervous system disorder | Mental disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Respiration Disorders | Inflammatory disorder | Communicable Diseases | Gastrointestinal Diseases chronic | Cardiovascular Diseases chronic | Nervous system disorder chronic | Mental disorders chronic | Metabolic Diseases chronic | Kidney Diseases chronic | Liver diseases chronic | Respiration Disorders chronic | Inflammatory disorder chronic | Communicable Diseases chronic | Malignant Neoplasms Requirement Pharmacotherapy | Disease Affecting Study Subject Participation Status | Disease Affecting Safety | Disease Affecting Research results

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0035204
UMLS CUI [9]
C1290884
UMLS CUI [10]
C0009450
UMLS CUI [11,1]
C0017178
UMLS CUI [11,2]
C0205191
UMLS CUI [12,1]
C0007222
UMLS CUI [12,2]
C0205191
UMLS CUI [13,1]
C0027765
UMLS CUI [13,2]
C0205191
UMLS CUI [14,1]
C0004936
UMLS CUI [14,2]
C0205191
UMLS CUI [15,1]
C0025517
UMLS CUI [15,2]
C0205191
UMLS CUI [16,1]
C0022658
UMLS CUI [16,2]
C0205191
UMLS CUI [17,1]
C0023895
UMLS CUI [17,2]
C0205191
UMLS CUI [18,1]
C0035204
UMLS CUI [18,2]
C0205191
UMLS CUI [19,1]
C1290884
UMLS CUI [19,2]
C0205191
UMLS CUI [20,1]
C0009450
UMLS CUI [20,2]
C0205191
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]
C0683954
use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives
Description

Concomitant Agent | Investigational New Drugs | Pharmaceutical Preparations | Drugs, Non-Prescription | Dietary Supplements | Exception Aspirin | Exception Acetaminophen | Exception Ibuprofen | Exception Oral Hormonal Contraceptives

Data type

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0013227
UMLS CUI [4]
C0013231
UMLS CUI [5]
C0242295
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0004057
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0000970
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0020740
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0009907
concomitant medications other than those listed above must have been discontinued at least 14 days before study entry
Description

Concomitant Agent Other To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1272691
currently active dermatitis or urticaria or diagnosis of eczema or psoriasis,
Description

Dermatitis | Urticaria | Eczema | Psoriasis

Data type

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)
Description

Drug Allergy | Anaphylaxis | Angioedema

Data type

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 ("daids grading table") 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.
Description

LABORATORY ABNORMALITIES | Serum creatinine measurement Grade | Hemoglobin measurement Grade | Platelet Count measurement Grade | Absolute neutrophil count Grade | Aspartate aminotransferase measurement Grade | Alanine aminotransferase measurement Grade | Serum total bilirubin measurement Grade | Laboratory test abnormality Grade

Data type

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2,1]
C0201976
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]
C0201899
UMLS CUI [6,2]
C0441800
UMLS CUI [7,1]
C0201836
UMLS CUI [7,2]
C0441800
UMLS CUI [8,1]
C1278039
UMLS CUI [8,2]
C0441800
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C0441800
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Similar models

Eligibility HIV NCT02404805

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT02404805
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 18-60 years
boolean
C0001779 (UMLS CUI [1])
HIV-1 Absent | HCV Antibodies Absent
Item
absence of hiv-1 and hcv antibodies at screening,
boolean
C0019704 (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 investigational drug study within 30 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Gastrointestinal Diseases | Cardiovascular Diseases | Nervous system disorder | Mental disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Respiration Disorders | Inflammatory disorder | Communicable Diseases | Gastrointestinal Diseases chronic | Cardiovascular Diseases chronic | Nervous system disorder chronic | Mental disorders chronic | Metabolic Diseases chronic | Kidney Diseases chronic | Liver diseases chronic | Respiration Disorders chronic | Inflammatory disorder chronic | Communicable Diseases chronic | Malignant Neoplasms Requirement Pharmacotherapy | Disease Affecting Study Subject Participation Status | Disease Affecting Safety | Disease Affecting 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])
C0007222 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
C1290884 (UMLS CUI [9])
C0009450 (UMLS CUI [10])
C0017178 (UMLS CUI [11,1])
C0205191 (UMLS CUI [11,2])
C0007222 (UMLS CUI [12,1])
C0205191 (UMLS CUI [12,2])
C0027765 (UMLS CUI [13,1])
C0205191 (UMLS CUI [13,2])
C0004936 (UMLS CUI [14,1])
C0205191 (UMLS CUI [14,2])
C0025517 (UMLS CUI [15,1])
C0205191 (UMLS CUI [15,2])
C0022658 (UMLS CUI [16,1])
C0205191 (UMLS CUI [16,2])
C0023895 (UMLS CUI [17,1])
C0205191 (UMLS CUI [17,2])
C0035204 (UMLS CUI [18,1])
C0205191 (UMLS CUI [18,2])
C1290884 (UMLS CUI [19,1])
C0205191 (UMLS CUI [19,2])
C0009450 (UMLS CUI [20,1])
C0205191 (UMLS CUI [20,2])
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])
C0683954 (UMLS CUI [24,3])
Concomitant Agent | Investigational New Drugs | Pharmaceutical Preparations | Drugs, Non-Prescription | Dietary Supplements | Exception Aspirin | Exception Acetaminophen | Exception Ibuprofen | Exception Oral Hormonal Contraceptives
Item
use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives
boolean
C2347852 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013227 (UMLS CUI [3])
C0013231 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0000970 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0020740 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0009907 (UMLS CUI [9,2])
Concomitant Agent Other To be stopped
Item
concomitant medications other than those listed above must have been discontinued at least 14 days before study entry
boolean
C2347852 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
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 ABNORMALITIES | Serum creatinine measurement Grade | Hemoglobin measurement Grade | Platelet Count measurement Grade | Absolute neutrophil count Grade | Aspartate aminotransferase measurement Grade | Alanine aminotransferase measurement Grade | Serum total bilirubin measurement Grade | Laboratory test abnormality 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 ("daids grading table") 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
C1853129 (UMLS CUI [1])
C0201976 (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])
C0201899 (UMLS CUI [6,1])
C0441800 (UMLS CUI [6,2])
C0201836 (UMLS CUI [7,1])
C0441800 (UMLS CUI [7,2])
C1278039 (UMLS CUI [8,1])
C0441800 (UMLS CUI [8,2])
C0438215 (UMLS CUI [9,1])
C0441800 (UMLS CUI [9,2])
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