Eligibility NCT00561925 HIV Infections
ODM derived from http://clinicaltrials.gov/show/NCT00561925

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (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
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0243009 (UMLS CUI 2011AA)
MTHU112269 (CTCAE 1105E)
C0015780 (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)
C0024554 (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)
C0015780 (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
C0015780 (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)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)