Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
Item
Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
boolean
C0011900 (UMLS CUI 1)
439401001 (SNOMED CT 1)
MTHU008876 (LOINC 1)
C0019693 (UMLS CUI 2)
86406008 (SNOMED CT 2)
10020161 (MedDRA 1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0013227 (UMLS CUI 3)
C1527415 (UMLS CUI 4)
26643006 (SNOMED CT 3)
_OralRoute (HL7 V3 2006_05)
C1963724 (UMLS CUI 5)
10067326 (MedDRA 2)
MTHU000163 (LOINC 2)
C1373111 (UMLS CUI 6)
C0033607 (UMLS CUI 7)
412127001 (SNOMED CT 4)
C1373120 (UMLS CUI 8)
Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
Item
Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
boolean
C0205225 (UMLS CUI [1])
C1373120 (UMLS CUI [2])
C0013203 (UMLS CUI [3])
Patient has previously received 2 different PI-based regimens
Item
Patient has previously received 2 different PI-based regimens
boolean
C0033607 (UMLS CUI 2011AA)
412127001 (SNOMED CT 2011_0131)
Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
Item
Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
boolean
C1373120 (UMLS CUI 2011AA)
Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
Item
Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
boolean
C1963724 (UMLS CUI 1)
10067326 (MedDRA 14.1)
MTHU000163 (LOINC Version 232)
C1320680 (UMLS CUI 2)
405786003 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
Item
Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
boolean
C2348568 (UMLS CUI 2011AA)
Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
Item
Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
boolean
C1444657 (UMLS CUI 1)
410536001 (SNOMED CT 1)
C0521115 (UMLS CUI 2)
79970003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 3)
Use of investigational ARVs (with exceptions)
Item
Use of investigational ARVs (with exceptions)
boolean
C0013230 (UMLS CUI 2011AA)
Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
Item
Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
boolean
C0205164 (UMLS CUI 1)
255603008 (SNOMED CT 1)
C0012634 (UMLS CUI 2)
64572001 (SNOMED CT 2)
Pregnant or breast-feeding female
Item
Pregnant or breast-feeding female
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
Female patient of childbearing potential not using effective non-hormonal birth control methods
Item
Female patient of childbearing potential not using effective non-hormonal birth control methods
boolean
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Patients with specific laboratory abnormalities
Item
Patients with specific laboratory abnormalities
boolean
Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
Item
Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
boolean
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)

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