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])
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])