ID

43381

Description

ODM derived from http://clinicaltrials.gov/show/NCT00561925

Lien

http://clinicaltrials.gov/show/NCT00561925

Mots-clés

Versions (3)
  1. 10/12/2013 10/12/2013 - Martin Dugas
  2. 15/04/2014 15/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility NCT00561925 HIV Infections

Allemand Anglais

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation
Description

Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation

Type de données

boolean

Alias
UMLS CUI 2011AA
C1561610
HL7 V3 2006_05
S
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C1706462
UMLS CUI 2011AA
CL426375
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C1704735
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot
Description

HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot

Type de données

boolean

Alias
UMLS CUI 2011AA
C2363741
MedDRA 14.1
10068341
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0242089
SNOMED CT 2011_0131
168276008
MedDRA 14.1
10050409
UMLS CUI 2011AA
C0014441
SNOMED CT 2011_0131
76978006
MedDRA 14.1
10059717
HL7 V3 2006_05
0070
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0949466
SNOMED CT 2011_0131
48745007
MedDRA 14.1
10050972
No previous antiretroviral treatment
Description

No previous antiretroviral treatment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1963724
MedDRA 14.1
10067326
LOINC Version 232
MTHU000163
Males with CD4+ counts >50 <400 cells/ml or females with CD4+ counts >50-<250 cells/ml
Description

Males with CD4+ counts >50 <400 cells/ml or females with CD4+ counts >50-<250 cells/ml

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0243009
CTCAE 1105E
MTHU112269
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0243009
CTCAE 1105E
MTHU112269
Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 mL/min according to the Cockcroft-Gault formula as follows: Male: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min). Female: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).
Description

Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 mL/min according to the Cockcroft-Gault formula as follows: Male: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min). Female: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C2711451
SNOMED CT 2011_0131
442407001
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
Karnofsky performance status (assessment scale)
Description

Karnofsky score >70 (see Appendix 10.4)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
An HIV-1 viral load of 1,000 copies/mL
Description

An HIV-1 viral load of 1,000 copies/mL

Type de données

boolean

Alias
UMLS CUI 2011AA
C0019704
SNOMED CT 2011_0131
89293008
MedDRA 14.1
10020192
LOINC Version 232
MTHU009425
UMLS CUI 2011AA
C0376705
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
Description

Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2

Type de données

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0243009
CTCAE 1105E
MTHU112269
UMLS CUI 2011AA
C0282515
SNOMED CT 2011_0131
268500004
MedDRA 14.1
10036895
UMLS CUI 2011AA
C0747031
MedDRA 14.1
10066696
Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.
Description

Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
CL068143
UMLS CUI 2011AA
C0683176
UMLS CUI 2011AA
C1515926
UMLS CUI 2011AA
C0032105
SNOMED CT 2011_0131
50863008
LOINC Version 232
MTHU002157
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0428212
SNOMED CT 2011_0131
365729004
UMLS CUI 2011AA
C1704675
UMLS CUI 2011AA
C0010762
SNOMED CT 2011_0131
424446007
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy.
Description

For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Active drug abuse or chronic alcoholism at the investigator's discretion
Description

Active drug abuse or chronic alcoholism at the investigator's discretion

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021430
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
Description

Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive

Type de données

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
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.
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.

Type de données

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
Laboratory parameters >DAIDS Grade 2
Description

Laboratory parameters >DAIDS Grade 2

Type de données

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
ALT/AST > DAIDS Grade 1
Description

ALT/AST > DAIDS Grade 1

Type de données

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
Hypersensitivity to any ingredients of the test products
Description

Hypersensitivity to any ingredients of the test products

Type de données

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
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)
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)

Type de données

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
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
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

Type de données

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
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
Description

Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information

Type de données

boolean

Alias
UMLS CUI 2011AA
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C1521941
LOINC Version 232
MTHU034709
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
Description

Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial

Type de données

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
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
Description

Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)

Type de données

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
Patients who have been diagnosed with malignant disease
Description

Patients who have been diagnosed with malignant disease

Type de données

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
Patients who in the opinion of the investigator are not candidates for inclusion in the study
Description

Patients who in the opinion of the investigator are not candidates for inclusion in the study

Type de données

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
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Description

Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma

Type de données

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
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
Description

Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit

Type de données

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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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation
Item
Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation
boolean
C1561610 (UMLS CUI 2011AA)
S (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1706462 (UMLS CUI 2011AA)
CL426375 (UMLS CUI 2011AA)
CL415116 (UMLS CUI 2011AA)
C1704735 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot
Item
HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot
boolean
C2363741 (UMLS CUI 2011AA)
10068341 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0242089 (UMLS CUI 2011AA)
168276008 (SNOMED CT 2011_0131)
10050409 (MedDRA 14.1)
C0014441 (UMLS CUI 2011AA)
76978006 (SNOMED CT 2011_0131)
10059717 (MedDRA 14.1)
0070 (HL7 V3 2006_05)
C0750484 (UMLS CUI 2011AA)
C0949466 (UMLS CUI 2011AA)
48745007 (SNOMED CT 2011_0131)
10050972 (MedDRA 14.1)
No previous antiretroviral treatment
Item
No previous antiretroviral treatment
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1963724 (UMLS CUI 2011AA)
10067326 (MedDRA 14.1)
MTHU000163 (LOINC Version 232)
Males with CD4+ counts >50 <400 cells/ml or females with CD4+ counts >50-<250 cells/ml
Item
Males with CD4+ counts >50 <400 cells/ml or females with CD4+ counts >50-<250 cells/ml
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0243009 (UMLS CUI 2011AA)
MTHU112269 (CTCAE 1105E)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0243009 (UMLS CUI 2011AA)
MTHU112269 (CTCAE 1105E)
Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 mL/min according to the Cockcroft-Gault formula as follows: Male: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min). Female: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).
Item
Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 mL/min according to the Cockcroft-Gault formula as follows: Male: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min). Female: (140 age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
Karnofsky score >70 (see Appendix 10.4)
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
An HIV-1 viral load of 1,000 copies/mL
Item
An HIV-1 viral load of 1,000 copies/mL
boolean
C0019704 (UMLS CUI 2011AA)
89293008 (SNOMED CT 2011_0131)
10020192 (MedDRA 14.1)
MTHU009425 (LOINC Version 232)
C0376705 (UMLS CUI 2011AA)
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
Item
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1704686 (UMLS CUI 2011AA)
C0243009 (UMLS CUI 2011AA)
MTHU112269 (CTCAE 1105E)
C0282515 (UMLS CUI 2011AA)
268500004 (SNOMED CT 2011_0131)
10036895 (MedDRA 14.1)
C0747031 (UMLS CUI 2011AA)
10066696 (MedDRA 14.1)
Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.
Item
Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
CL068143 (UMLS CUI 2011AA)
C0683176 (UMLS CUI 2011AA)
C1515926 (UMLS CUI 2011AA)
C0032105 (UMLS CUI 2011AA)
50863008 (SNOMED CT 2011_0131)
MTHU002157 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0428212 (UMLS CUI 2011AA)
365729004 (SNOMED CT 2011_0131)
C1704675 (UMLS CUI 2011AA)
C0010762 (UMLS CUI 2011AA)
424446007 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy.
Item
For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy.
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Active drug abuse or chronic alcoholism at the investigator's discretion
Item
Active drug abuse or chronic alcoholism at the investigator's discretion
boolean
C0021430 (UMLS CUI 2011AA)
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
Item
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C1096264 (UMLS CUI 2011AA)
10054262 (MedDRA 14.1)
C0369335 (UMLS CUI 2011AA)
121204002 (SNOMED CT 2011_0131)
MTHU001816 (LOINC Version 232)
CL415097 (UMLS CUI 2011AA)
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.
Item
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.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
CL025474 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0015011 (UMLS CUI 2011AA)
126097006 (SNOMED CT 2011_0131)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
Laboratory parameters >DAIDS Grade 2
Item
Laboratory parameters >DAIDS Grade 2
boolean
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0449381 (UMLS CUI 2011AA)
252116004 (SNOMED CT 2011_0131)
C2919030 (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)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
ALT/AST > DAIDS Grade 1
Item
ALT/AST > DAIDS Grade 1
boolean
C0799489 (UMLS CUI 2011AA)
16325-3 (LOINC Version 232)
C2919030 (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)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
Hypersensitivity to any ingredients of the test products
Item
Hypersensitivity to any ingredients of the test products
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1705248 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
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)
Item
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)
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C0599685 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C2700409 (UMLS CUI 2011AA)
C0242781 (UMLS CUI 2011AA)
C0026591 (UMLS CUI 2011AA)
72705000 (SNOMED CT 2011_0131)
MTHU035602 (LOINC Version 232)
MTH (HL7 V3 2006_05)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
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
Item
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
boolean
C0332325 (UMLS CUI 2011AA)
30714006 (SNOMED CT 2011_0131)
C1373120 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
C1528494 (UMLS CUI 2011AA)
C0909839 (UMLS CUI 2011AA)
404856006 (SNOMED CT 2011_0131)
MTHU018643 (LOINC Version 232)
C1099776 (UMLS CUI 2011AA)
385556006 (SNOMED CT 2011_0131)
C0209738 (UMLS CUI 2011AA)
386897000 (SNOMED CT 2011_0131)
MTHU013847 (LOINC Version 232)
C0019704 (UMLS CUI 2011AA)
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)
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
Item
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
boolean
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C1707479 (UMLS CUI 2011AA)
C1521941 (UMLS CUI 2011AA)
MTHU034709 (LOINC Version 232)
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
Item
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
boolean
C1524063 (UMLS CUI 2011AA)
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)
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
Item
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
boolean
C1524063 (UMLS CUI 2011AA)
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)
Patients who have been diagnosed with malignant disease
Item
Patients who have been diagnosed with malignant disease
boolean
C0011900 (UMLS CUI 2011AA)
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)
Patients who in the opinion of the investigator are not candidates for inclusion in the study
Item
Patients who in the opinion of the investigator are not candidates for inclusion in the study
boolean
C0022423 (UMLS CUI 2011AA)
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)
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Item
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
boolean
C0023524 (UMLS CUI 2011AA)
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)
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
Item
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
boolean
C0221423 (UMLS CUI 2011AA)
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)
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