ID

10249

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00531206 Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients NCT00531206

Link

http://clinicaltrials.gov/show/NCT00531206

Palavras-chave

Versões (2)
  1. 14/04/2014 14/04/2014 - Julian Varghese
  2. 22/05/2015 22/05/2015 - Martin Dugas
Transferido a

22 de maio de 2015

DOI

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Licença

Creative Commons BY 4.0
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HIV Eligibility NCT00531206

Alemão Inglês

Eligibility HIV NCT00531206

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT00531206
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age at least 18 Years
Descrição

age at least 18 Years

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
397669002
UMLS CUI-1
C0001779
Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
Descrição

Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
75540009
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
41847000
SNOMED CT 2011_0131
409795000
SNOMED CT 2011_0131
255204007
SNOMED CT 2011_0131
412127001
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
SNOMED CT 2011_0131
410535002
SNOMED CT 2011_0131
229554006
MedDRA 14.1
10067326
LOINC Version 232
MTHU000163
MedDRA 14.1
10068341
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI-1
C1444092
UMLS CUI-2
C0439064
UMLS CUI-3
C0033607
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Age < 18 years
Descrição

Age < 18 years

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
397669002
UMLS CUI-1
C0001779
pregnant female patients
Descrição

pregnant female patients

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0549206
Hypersensitivity to the active substance or to any of the excipients.
Descrição

Hypersensitivity to the active substance or to any of the excipients.

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
SNOMED CT 2011_0131
55561003
SNOMED CT 2011_0131
360215002
UMLS CUI-1
C0020517
UMLS CUI-2
C0013227
Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
Descrição

Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
24484000
MedDRA 14.1
10052254
UMLS CUI-1
C0948807
Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
Descrição

Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
387159009
LOINC Version 232
MTHU008474
SNOMED CT 2011_0131
229554006
SNOMED CT 2011_0131
260370003
UMLS CUI-1
C0035608
UMLS CUI-2
C1612190
Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
Descrição

Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
260676000
SNOMED CT 2011_0131
42504009
SNOMED CT 2011_0131
51621002
SNOMED CT 2011_0131
371881003
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
SNOMED CT 2011_0131
1250004
HL7 V3 2006_05
D
SNOMED CT 2011_0131
260400001
SNOMED CT 2011_0131
58147004
SNOMED CT 2011_0131
253861007
UMLS CUI-1
C1360419
UMLS CUI-2
C0936242
Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
Descrição

Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.

Tipo de dados

boolean

Alias
SNOMED CT 2011_0131
410536001
SNOMED CT 2011_0131
416118004
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
SNOMED CT 2011_0131
55561003
SNOMED CT 2011_0131
75540009
SNOMED CT 2011_0131
371154000
SNOMED CT 2011_0131
47429007
SNOMED CT 2011_0131
440181000
SNOMED CT 2011_0131
288556008
SNOMED CT 2011_0131
55561003
SNOMED CT 2011_0131
55919000
SNOMED CT 2011_0131
67507000
SNOMED CT 2011_0131
372821002
LOINC Version 232
MTHU004841
SNOMED CT 2011_0131
372503006
SNOMED CT 2011_0131
372697008
LOINC Version 232
MTHU005039
SNOMED CT 2011_0131
372806008
LOINC Version 232
MTHU003328
SNOMED CT 2011_0131
387333002
LOINC Version 232
MTHU002553
SNOMED CT 2011_0131
387089004
LOINC Version 232
MTHU003387
SNOMED CT 2011_0131
387267005
SNOMED CT 2011_0131
126071000
SNOMED CT 2011_0131
395975005
LOINC Version 232
MTHU024862
SNOMED CT 2011_0131
126074008
LOINC Version 232
MTHU007397
SNOMED CT 2011_0131
387164008
LOINC Version 232
MTHU012783
SNOMED CT 2011_0131
10784006, 372482001
LOINC Version 232
MTHU003337
SNOMED CT 2011_0131
386848009
LOINC Version 232
MTHU003380
SNOMED CT 2011_0131
418732002
SNOMED CT 2011_0131
372614000
SNOMED CT 2011_0131
372585002
LOINC Version 232
MTHU015316
SNOMED CT 2011_0131
386984001
LOINC Version 232
MTHU003366
SNOMED CT 2011_0131
372912004
SNOMED CT 2011_0131
387584000
SNOMED CT 2011_0131
96303004
SNOMED CT 2011_0131
410536001
SNOMED CT 2011_0131
416118004
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
SNOMED CT 2011_0131
75540009
SNOMED CT 2011_0131
371154000
SNOMED CT 2011_0131
67507000
SNOMED CT 2011_0131
372751001
LOINC Version 232
MTHU004259
SNOMED CT 2011_0131
372910007
LOINC Version 232
MTHU012323
UMLS CUI-1
C0059563
UMLS CUI-2
C0013227
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Similar models

Eligibility HIV NCT00531206

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT00531206
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age at least 18 Years
Item
age at least 18 Years
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
Resistant to multiple protease inhibitors
Item
Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
boolean
75540009 (SNOMED CT 2011_0131)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
41847000 (SNOMED CT 2011_0131)
409795000 (SNOMED CT 2011_0131)
255204007 (SNOMED CT 2011_0131)
412127001 (SNOMED CT 2011_0131)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
410535002 (SNOMED CT 2011_0131)
229554006 (SNOMED CT 2011_0131)
10067326 (MedDRA 14.1)
MTHU000163 (LOINC Version 232)
10068341 (MedDRA 14.1)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1444092 (UMLS CUI-1)
C0439064 (UMLS CUI-2)
C0033607 (UMLS CUI-3)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Age below 18 years
Item
Age < 18 years
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
pregnant female patients
Item
pregnant female patients
boolean
C0549206 (UMLS CUI 2011AA)
Hypersensitivity to the active substance or to any of the excipients.
Item
Hypersensitivity to the active substance or to any of the excipients.
boolean
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
55561003 (SNOMED CT 2011_0131)
360215002 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Patients with moderate or severe hepatic impairment.
Item
Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
boolean
24484000 (SNOMED CT 2011_0131)
10052254 (MedDRA 14.1)
C0948807 (UMLS CUI-1)
Rifampicin and Aptivus
Item
Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
boolean
387159009 (SNOMED CT 2011_0131)
MTHU008474 (LOINC Version 232)
229554006 (SNOMED CT 2011_0131)
260370003 (SNOMED CT 2011_0131)
C0035608 (UMLS CUI-1)
C1612190 (UMLS CUI-2)
Herbal preparations containing St John's wort
Item
Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
boolean
260676000 (SNOMED CT 2011_0131)
42504009 (SNOMED CT 2011_0131)
51621002 (SNOMED CT 2011_0131)
371881003 (SNOMED CT 2011_0131)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
1250004 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
260400001 (SNOMED CT 2011_0131)
58147004 (SNOMED CT 2011_0131)
253861007 (SNOMED CT 2011_0131)
C1360419 (UMLS CUI-1)
C0936242 (UMLS CUI-2)
CYP3A dependent substances
Item
Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
boolean
410536001 (SNOMED CT 2011_0131)
416118004 (SNOMED CT 2011_0131)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
55561003 (SNOMED CT 2011_0131)
75540009 (SNOMED CT 2011_0131)
371154000 (SNOMED CT 2011_0131)
47429007 (SNOMED CT 2011_0131)
440181000 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131)
55561003 (SNOMED CT 2011_0131)
55919000 (SNOMED CT 2011_0131)
67507000 (SNOMED CT 2011_0131)
372821002 (SNOMED CT 2011_0131)
MTHU004841 (LOINC Version 232)
372503006 (SNOMED CT 2011_0131)
372697008 (SNOMED CT 2011_0131)
MTHU005039 (LOINC Version 232)
372806008 (SNOMED CT 2011_0131)
MTHU003328 (LOINC Version 232)
387333002 (SNOMED CT 2011_0131)
MTHU002553 (LOINC Version 232)
387089004 (SNOMED CT 2011_0131)
MTHU003387 (LOINC Version 232)
387267005 (SNOMED CT 2011_0131)
126071000 (SNOMED CT 2011_0131)
395975005 (SNOMED CT 2011_0131)
MTHU024862 (LOINC Version 232)
126074008 (SNOMED CT 2011_0131)
MTHU007397 (LOINC Version 232)
387164008 (SNOMED CT 2011_0131)
MTHU012783 (LOINC Version 232)
10784006, 372482001 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
386848009 (SNOMED CT 2011_0131)
MTHU003380 (LOINC Version 232)
418732002 (SNOMED CT 2011_0131)
372614000 (SNOMED CT 2011_0131)
372585002 (SNOMED CT 2011_0131)
MTHU015316 (LOINC Version 232)
386984001 (SNOMED CT 2011_0131)
MTHU003366 (LOINC Version 232)
372912004 (SNOMED CT 2011_0131)
387584000 (SNOMED CT 2011_0131)
96303004 (SNOMED CT 2011_0131)
410536001 (SNOMED CT 2011_0131)
416118004 (SNOMED CT 2011_0131)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
75540009 (SNOMED CT 2011_0131)
371154000 (SNOMED CT 2011_0131)
67507000 (SNOMED CT 2011_0131)
372751001 (SNOMED CT 2011_0131)
MTHU004259 (LOINC Version 232)
372910007 (SNOMED CT 2011_0131)
MTHU012323 (LOINC Version 232)
C0059563 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
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