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])
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])