ID
43381
Description
ODM derived from http://clinicaltrials.gov/show/NCT00561925
Link
http://clinicaltrials.gov/show/NCT00561925
Keywords
Versions (3)
- 12/10/13 12/10/13 - Martin Dugas
- 4/15/14 4/15/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00561925 HIV Infections
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
Active drug abuse or chronic alcoholism at the investigator's discretion
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0021430
Description
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- C1704788
- UMLS CUI 2011AA
- C0149709
- SNOMED CT 2011_0131
- 165806002
- MedDRA 14.1
- 10019742
- UMLS CUI 2011AA
- C1096264
- MedDRA 14.1
- 10054262
- UMLS CUI 2011AA
- C0369335
- SNOMED CT 2011_0131
- 121204002
- LOINC Version 232
- MTHU001816
- UMLS CUI 2011AA
- CL415097
Description
Female patients of child-bearing potential who: are pregnant at screening, are breast feeding, are planning to become pregnant are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives. Note: During participation in this study, females and males have to use barrier methods of contraception in addition or instead of ethinyl estradiol containing oral contraceptives.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- CL025474
- UMLS CUI 2011AA
- C0032961
- SNOMED CT 2011_0131
- 289908002
- MedDRA 14.1
- 10036556
- LOINC Version 232
- MTHU035048
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0600109
- SNOMED CT 2011_0131
- 225466006
- UMLS CUI 2011AA
- C0004764
- SNOMED CT 2011_0131
- 225370004
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0015011
- SNOMED CT 2011_0131
- 126097006
- UMLS CUI 2011AA
- C0332256
- SNOMED CT 2011_0131
- 42504009
- UMLS CUI 2011AA
- C0009905
- SNOMED CT 2011_0131
- 59261009
Description
Laboratory parameters >DAIDS Grade 2
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C0449381
- SNOMED CT 2011_0131
- 252116004
- UMLS CUI 2011AA
- C2919030
- UMLS CUI 2011AA
- C0001175
- SNOMED CT 2011_0131
- 62479008
- MedDRA 14.1
- 10000565
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Description
ALT/AST > DAIDS Grade 1
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0799489
- LOINC Version 232
- 16325-3
- UMLS CUI 2011AA
- C2919030
- UMLS CUI 2011AA
- C0001175
- SNOMED CT 2011_0131
- 62479008
- MedDRA 14.1
- 10000565
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Description
Hypersensitivity to any ingredients of the test products
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C0013230
Description
Previous use of Viramune (nevirapine) or any other antiretroviral agents (does not include use of single dose NVP for the prevention of mother to child transmission)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0132326
- SNOMED CT 2011_0131
- 386898005
- LOINC Version 232
- MTHU013861
- UMLS CUI 2011AA
- C0599685
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0205171
- SNOMED CT 2011_0131
- 50607009
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0132326
- SNOMED CT 2011_0131
- 386898005
- LOINC Version 232
- MTHU013861
- UMLS CUI 2011AA
- C2700409
- UMLS CUI 2011AA
- C0242781
- UMLS CUI 2011AA
- C0026591
- SNOMED CT 2011_0131
- 72705000
- LOINC Version 232
- MTHU035602
- HL7 V3 2006_05
- MTH
- UMLS CUI 2011AA
- C0008059
- SNOMED CT 2011_0131
- 67822003
- HL7 V3 2006_05
- CHILD
Description
Resistance to NNRTIs or either one of the components of Truvada (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on HIV-1 genotypic resistance testing report obtained at screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332325
- SNOMED CT 2011_0131
- 30714006
- UMLS CUI 2011AA
- C1373120
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C1528494
- UMLS CUI 2011AA
- C0909839
- SNOMED CT 2011_0131
- 404856006
- LOINC Version 232
- MTHU018643
- UMLS CUI 2011AA
- C1099776
- SNOMED CT 2011_0131
- 385556006
- UMLS CUI 2011AA
- C0209738
- SNOMED CT 2011_0131
- 386897000
- LOINC Version 232
- MTHU013847
- UMLS CUI 2011AA
- C0019704
- SNOMED CT 2011_0131
- 89293008
- MedDRA 14.1
- 10020192
- LOINC Version 232
- MTHU009425
- UMLS CUI 2011AA
- C0017431
- UMLS CUI 2011AA
- C0332325
- SNOMED CT 2011_0131
- 30714006
- UMLS CUI 2011AA
- C0392366
- SNOMED CT 2011_0131
- C47891
- UMLS CUI 2011AA
- C0684224
- SNOMED CT 2011_0131
- 229059009
- UMLS CUI 2011AA
- C1409616
Description
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C1521941
- LOINC Version 232
- MTHU034709
Description
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- CL031856
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0005525
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0021747
- SNOMED CT 2011_0131
- 49327004
- LOINC Version 232
- MTHU021353
- UMLS CUI 2011AA
- C0010592
- SNOMED CT 2011_0131
- 387467008
- LOINC Version 232
- MTHU005140
- UMLS CUI 2011AA
- C0020402
- SNOMED CT 2011_0131
- 56602009
- UMLS CUI 2011AA
- C0021756
- SNOMED CT 2011_0131
- 68945006
- LOINC Version 232
- MTHU015779
Description
Patients who have been diagnosed with malignant disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
Description
Patients who in the opinion of the investigator are not candidates for inclusion in the study
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- C1548788
- UMLS CUI 2011AA
- CL425202
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0023524
- SNOMED CT 2011_0131
- 22255007
- MedDRA 14.1
- 10036807
- ICD-10-CM Version 2010
- A81.2
- ICD-9-CM Version 2011
- 046.3
- UMLS CUI 2011AA
- C0864942
- UMLS CUI 2011AA
- C0024299
- SNOMED CT 2011_0131
- 21964009
- MedDRA 14.1
- 10025310
- ICD-10-CM Version 2010
- C85.9
Description
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0221423
- SNOMED CT 2011_0131
- 39104002
- MedDRA 14.1
- 10040658
- ICD-10-CM Version 2010
- R69
- UMLS CUI 2011AA
- C1704788
- UMLS CUI 2011AA
- C0001175
- SNOMED CT 2011_0131
- 62479008
- MedDRA 14.1
- 10000565
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
- UMLS CUI 2011AA
- C0443342
- SNOMED CT 2011_0131
- 263921008
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0443343
- SNOMED CT 2011_0131
- 263922001
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
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Eligibility
- StudyEvent: Eligibility
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C0232804 (UMLS CUI 2011AA)
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C1704788 (UMLS CUI 2011AA)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
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248153007 (SNOMED CT 2011_0131)
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10040230 (MedDRA 14.1)
C0086287 (UMLS CUI 2011AA)
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C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
273546003 (SNOMED CT 2011_0131)
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10020192 (MedDRA 14.1)
MTHU009425 (LOINC Version 232)
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10019731 (MedDRA 14.1)
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C0015011 (UMLS CUI 2011AA)
126097006 (SNOMED CT 2011_0131)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
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89293008 (SNOMED CT 2011_0131)
10020192 (MedDRA 14.1)
MTHU009425 (LOINC Version 232)
C0017431 (UMLS CUI 2011AA)
C0332325 (UMLS CUI 2011AA)
30714006 (SNOMED CT 2011_0131)
C0392366 (UMLS CUI 2011AA)
C47891 (SNOMED CT 2011_0131)
C0684224 (UMLS CUI 2011AA)
229059009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
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C1707479 (UMLS CUI 2011AA)
C1521941 (UMLS CUI 2011AA)
MTHU034709 (LOINC Version 232)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0021747 (UMLS CUI 2011AA)
49327004 (SNOMED CT 2011_0131)
MTHU021353 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0021756 (UMLS CUI 2011AA)
68945006 (SNOMED CT 2011_0131)
MTHU015779 (LOINC Version 232)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C1548788 (UMLS CUI 2011AA)
CL425202 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
22255007 (SNOMED CT 2011_0131)
10036807 (MedDRA 14.1)
A81.2 (ICD-10-CM Version 2010)
046.3 (ICD-9-CM Version 2011)
C0864942 (UMLS CUI 2011AA)
C0024299 (UMLS CUI 2011AA)
21964009 (SNOMED CT 2011_0131)
10025310 (MedDRA 14.1)
C85.9 (ICD-10-CM Version 2010)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C1704788 (UMLS CUI 2011AA)
C0001175 (UMLS CUI 2011AA)
62479008 (SNOMED CT 2011_0131)
10000565 (MedDRA 14.1)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0443342 (UMLS CUI 2011AA)
263921008 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)