Eligibility NCT00543803 HIV Infections
ODM derived from http://clinicaltrials.gov/show/NCT00543803

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)
male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
Item
male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0700597 (UMLS CUI 2011AA)
41847000 (SNOMED CT 2011_0131)
C2363741 (UMLS CUI 2011AA)
10068341 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C0033607 (UMLS CUI 2011AA)
412127001 (SNOMED CT 2011_0131)
C0231175 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C2919691 (UMLS CUI 2011AA)
445528004 (SNOMED CT 2011_0131)
C0033607 (UMLS CUI 2011AA)
412127001 (SNOMED CT 2011_0131)
C1373120 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
CL330043 (UMLS CUI 2011AA)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0877596 (UMLS CUI 2011AA)
10049835 (MedDRA 14.1)
CL384716 (UMLS CUI 2011AA)
C2718050 (UMLS CUI 2011AA)
Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Item
Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
boolean
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C1292711 (UMLS CUI 2011AA)
123005000 (SNOMED CT 2011_0131)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C2363964 (UMLS CUI 2011AA)
10068724 (MedDRA 14.1)
C2363741 (UMLS CUI 2011AA)
10068341 (MedDRA 14.1)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0205329 (UMLS CUI 2011AA)
255314001 (SNOMED CT 2011_0131)
C0021051 (UMLS CUI 2011AA)
234532001 (SNOMED CT 2011_0131)
10061598 (MedDRA 14.1)
D84.9 (ICD-10-CM Version 2010)
279.3 (ICD-9-CM Version 2011)
Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Item
Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
boolean
C1528494 (UMLS CUI 2011AA)
C0384228 (UMLS CUI 2011AA)
422091007 (SNOMED CT 2011_0131)
MTHU015506 (LOINC Version 232)
C0909839 (UMLS CUI 2011AA)
404856006 (SNOMED CT 2011_0131)
MTHU018643 (LOINC Version 232)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C1963724 (UMLS CUI 2011AA)
10067326 (MedDRA 14.1)
MTHU000163 (LOINC Version 232)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2363741 (UMLS CUI 2011AA)
10068341 (MedDRA 14.1)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Age < 18 years
Item
Age < 18 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pregnant female patients
Item
Pregnant female patients
boolean
C0549206 (UMLS CUI 2011AA)
Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
Item
Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C1528494 (UMLS CUI 2011AA)
C0384228 (UMLS CUI 2011AA)
422091007 (SNOMED CT 2011_0131)
MTHU015506 (LOINC Version 232)
C0909839 (UMLS CUI 2011AA)
404856006 (SNOMED CT 2011_0131)
MTHU018643 (LOINC Version 232)
Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Item
Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
boolean
C0376495 (UMLS CUI 2011AA)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0015230 (UMLS CUI 2011AA)
112625008 (SNOMED CT 2011_0131)
10037844 (MedDRA 14.1)
MTHU015064 (LOINC Version 232)
R21 (ICD-10-CM Version 2010)
782.1 (ICD-9-CM Version 2011)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0009812 (UMLS CUI 2011AA)
MTHU034799 (LOINC Version 232)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) > 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised < 5 ULN.
Item
Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) > 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised < 5 ULN.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
C2347612 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
CL415091 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C1293130 (UMLS CUI 2011AA)
115979005 (SNOMED CT 2011_0131)
Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT > 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
Item
Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT > 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
boolean
C0376495 (UMLS CUI 2011AA)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C2825055 (UMLS CUI 2011AA)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C0376495 (UMLS CUI 2011AA)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
Item
Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1360419 (UMLS CUI 2011AA)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0936242 (UMLS CUI 2011AA)
51621002 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
CL420107 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0205216 (UMLS CUI 2011AA)
1250004 (SNOMED CT 2011_0131)
C0683150 (UMLS CUI 2011AA)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.
Item
The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.
boolean
CL415222 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0035608 (UMLS CUI 2011AA)
387159009 (SNOMED CT 2011_0131)
MTHU008474 (LOINC Version 232)
C0132326 (UMLS CUI 2011AA)
386898005 (SNOMED CT 2011_0131)
MTHU013861 (LOINC Version 232)
CL420107 (UMLS CUI 2011AA)
C0031328 (UMLS CUI 2011AA)
C1511726 (UMLS CUI 2011AA)
C0038659 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)