ID

42097

Description

ODM derived from http://clinicaltrials.gov/show/NCT00354627

Link

http://clinicaltrials.gov/show/NCT00354627

Keywords

Versions (3)
  1. 3/13/12 3/13/12 -
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 4/9/21 4/9/21 - Ahmed Rafee, MD
Copyright Holder

AR

Uploaded on

April 9, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00354627 HIV-1

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
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])
Description

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])

Data type

boolean

Alias
UMLS CUI 1
C0011900
SNOMED CT 1
439401001
LOINC 1
MTHU008876
UMLS CUI 2
C0019693
SNOMED CT 2
86406008
MedDRA 1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 3
C0013227
UMLS CUI 4
C1527415
SNOMED CT 3
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 5
C1963724
MedDRA 2
10067326
LOINC 2
MTHU000163
UMLS CUI 6
C1373111
UMLS CUI 7
C0033607
SNOMED CT 4
412127001
UMLS CUI 8
C1373120
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0205225
UMLS CUI [2]
C1373120
UMLS CUI [3]
C0013203
Patient has previously received 2 different PI-based regimens
Description

Patient has previously received 2 different PI-based regimens

Data type

boolean

Alias
UMLS CUI 2011AA
C0033607
SNOMED CT 2011_0131
412127001
Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
Description

Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance

Data type

boolean

Alias
UMLS CUI 2011AA
C1373120
Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
Description

Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.

Data type

boolean

Alias
UMLS CUI 1
C1963724
MedDRA 14.1
10067326
LOINC Version 232
MTHU000163
UMLS CUI 2
C1320680
SNOMED CT 2011_0131
405786003
Exclusion Criteria
Description

Exclusion Criteria

Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
Description

Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
Description

Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)

Data type

boolean

Alias
UMLS CUI 1
C1444657
SNOMED CT 1
410536001
UMLS CUI 2
C0521115
SNOMED CT 2011_0131
79970003
UMLS CUI 3
C0039798
Use of investigational ARVs (with exceptions)
Description

Use of investigational ARVs (with exceptions)

Data type

boolean

Alias
UMLS CUI 2011AA
C0013230
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
Description

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

Data type

boolean

Alias
UMLS CUI 1
C0205164
SNOMED CT 1
255603008
UMLS CUI 2
C0012634
SNOMED CT 2
64572001
Pregnant or breast-feeding female
Description

Pregnant or breast-feeding female

Data type

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
Female patient of childbearing potential not using effective non-hormonal birth control methods
Description

Female patient of childbearing potential not using effective non-hormonal birth control methods

Data type

boolean

Alias
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Patients with specific laboratory abnormalities
Description

Patients with specific laboratory abnormalities

Data type

boolean

Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
Description

Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.

Data type

boolean

Alias
UMLS CUI 2011AA
C1869009
MedDRA 14.1
20000005
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Similar models

Eligibility

1 forms
  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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