ID

4575

Beschrijving

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

Trefwoorden

Versies (1)
  1. 11-12-13 11-12-13 - Martin Dugas
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11 december 2013

DOI

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00144287 # HIV-1 Infection

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschrijving

Inclusion criteria

No Healthy Volunteers
Beschrijving

Healthy Volunteers

Datatype

boolean

Alias
UMLS CUI
C1708335
Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
Beschrijving

InclusionCriterion_1

Datatype

boolean

Alias
UMLS CUI
C0238607
UMLS CUI
C1963724
LNC
MTHU000163
MDR
10067326
UMLS CUI
C1961133
SNOMED CT 2010_0731
425824001
UMLS CUI
C1510425
Age >= 18 years
Beschrijving

InclusionCriterion_2

Datatype

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
Beschrijving

InclusionCriterion_3

Datatype

boolean

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Patient voluntarily provides written informed consent to participate, in compliance with local law
Beschrijving

InclusionCriterion_4

Datatype

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Beschrijving

Exclusion criteria

Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
Beschrijving

ExclusionCriterion_1

Datatype

boolean

Alias
UMLS CUI
C0013182
HL7V3.0
DALG
ICD10CM
T88.7
MDR
10013700
SNOMED CT 2010_0731
416098002
UMLS CUI
C0663733
LNC
MTHU019174
SNOMED CT 2010_0731
419409009
UMLS CUI
C0292818
LNC
MTHU013855
SNOMED CT 2010_0731
386896009
Required use of restricted medications
Beschrijving

ExclusionCriterion_2

Datatype

boolean

Alias
UMLS CUI
CL357089
UMLS CUI
C0013227
LNC
MTHU008870
SNOMED CT 2010_0731
410942007
Female patients of childbearing potential who: - Have a positive pregnancy test at baseline or - Are breast feeding.
Beschrijving

ExclusionCriterion_3

Datatype

boolean

Alias
UMLS CUI
C0240802
MDR
10036575
SNOMED CT 2010_0731
250423000
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
Any medical condition(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
Beschrijving

ExclusionCriterion_4

Datatype

boolean

Alias
UMLS CUI
CL102947
Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
Beschrijving

ExclusionCriterion_5

Datatype

boolean

Alias
UMLS CUI
C0013230
UMLS CUI
C1977399
LNC
MTHU026517
Hepatic impairment(*) evidenced by the following baseline laboratory findings: - AST or ALT >5X upper limit of normal (ULN) or total bilirubin >3.5X ULN or - AST or ALT >2.5X ULN and total bilirubin >2X ULN (*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.
Beschrijving

ExclusionCriterion_6

Datatype

boolean

Alias
UMLS CUI
C0086565
MDR
10019670
SNOMED CT 2010_0731
75183008
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
LNC
MTHU004883
UMLS CUI
C0364055
LNC
1920-8
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
LNC
MTHU006766
UMLS CUI
C0363876
LNC
1742-6
UMLS CUI
C0857545
MDR
10005368
UMLS CUI
C0364108
LNC
1975-2
Medical Concepts
Beschrijving

Medical Concepts

Healthy Subject
Beschrijving

Healthy Subject

Datatype

string

Alias
UMLS CUI
C1708335
AIDS PATIENT
Beschrijving

AIDS PATIENT

Datatype

string

Alias
UMLS CUI
C0238607
Antiretroviral therapy
Beschrijving

Antiretroviral therapy

Datatype

string

Alias
UMLS CUI
C1963724
LNC
MTHU000163
MDR
10067326
Proteinase inhibitor
Beschrijving

Proteinase inhibitor

Datatype

string

Alias
UMLS CUI
C1961133
SNOMED CT 2010_0731
425824001
Anti-HIV Therapy
Beschrijving

Anti-HIV Therapy

Datatype

string

Alias
UMLS CUI
C1510425
Age
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Contraceptive methods
Beschrijving

Contraceptive methods

Datatype

string

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Informed Consent
Beschrijving

Informed Consent

Datatype

string

Alias
UMLS CUI
C0021430
Drug Allergy
Beschrijving

Drug Allergy

Datatype

string

Alias
UMLS CUI
C0013182
HL7V3.0
DALG
ICD10CM
T88.7
MDR
10013700
SNOMED CT 2010_0731
416098002
Tipranavir
Beschrijving

Tipranavir

Datatype

string

Alias
UMLS CUI
C0663733
LNC
MTHU019174
SNOMED CT 2010_0731
419409009
Ritonavir
Beschrijving

Ritonavir

Datatype

string

Alias
UMLS CUI
C0292818
LNC
MTHU013855
SNOMED CT 2010_0731
386896009
Restriction
Beschrijving

Restriction

Datatype

string

Alias
UMLS CUI
CL357089
Pharmaceutical Preparations
Beschrijving

Pharmaceutical Preparations

Datatype

string

Alias
UMLS CUI
C0013227
LNC
MTHU008870
SNOMED CT 2010_0731
410942007
Positive Pregnancy Test
Beschrijving

Positive Pregnancy Test

Datatype

string

Alias
UMLS CUI
C0240802
MDR
10036575
SNOMED CT 2010_0731
250423000
Breast Feeding
Beschrijving

Breast Feeding

Datatype

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
Investigator
Beschrijving

Investigator

Datatype

string

Alias
UMLS CUI
CL102947
Investigational New Drug
Beschrijving

Investigational New Drug

Datatype

string

Alias
UMLS CUI
C0013230
Tipranavir+Ritonavir
Beschrijving

Tipranavir+Ritonavir

Datatype

string

Alias
UMLS CUI
C1977399
LNC
MTHU026517
Liver Dysfunction
Beschrijving

Liver Dysfunction

Datatype

string

Alias
UMLS CUI
C0086565
MDR
10019670
SNOMED CT 2010_0731
75183008
Aspartate Transaminase
Beschrijving

Aspartate Transaminase

Datatype

string

Alias
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
LNC
MTHU004883
Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn
Beschrijving

Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn

Datatype

string

Alias
UMLS CUI
C0364055
LNC
1920-8
Alanine Transaminase
Beschrijving

Alanine Transaminase

Datatype

string

Alias
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
LNC
MTHU006766
Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn
Beschrijving

Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn

Datatype

string

Alias
UMLS CUI
C0363876
LNC
1742-6
Blood bilirubin total
Beschrijving

Blood bilirubin total

Datatype

string

Alias
UMLS CUI
C0857545
MDR
10005368
Bilirubin:MCnc:Pt:Ser/Plas:Qn
Beschrijving

Bilirubin:MCnc:Pt:Ser/Plas:Qn

Datatype

string

Alias
UMLS CUI
C0364108
LNC
1975-2
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion criteria
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
boolean
C0238607 (UMLS CUI)
C1963724 (UMLS CUI)
MTHU000163 (LNC)
10067326 (MDR)
C1961133 (UMLS CUI)
425824001 (SNOMED CT 2010_0731)
C1510425 (UMLS CUI)
InclusionCriterion_2
Item
Age >= 18 years
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_3
Item
Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
boolean
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
InclusionCriterion_4
Item
Patient voluntarily provides written informed consent to participate, in compliance with local law
boolean
C0021430 (UMLS CUI)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
boolean
C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
C0663733 (UMLS CUI)
MTHU019174 (LNC)
419409009 (SNOMED CT 2010_0731)
C0292818 (UMLS CUI)
MTHU013855 (LNC)
386896009 (SNOMED CT 2010_0731)
ExclusionCriterion_2
Item
Required use of restricted medications
boolean
CL357089 (UMLS CUI)
C0013227 (UMLS CUI)
MTHU008870 (LNC)
410942007 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
Female patients of childbearing potential who: - Have a positive pregnancy test at baseline or - Are breast feeding.
boolean
C0240802 (UMLS CUI)
10036575 (MDR)
250423000 (SNOMED CT 2010_0731)
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
Any medical condition(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
boolean
CL102947 (UMLS CUI)
ExclusionCriterion_5
Item
Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
boolean
C0013230 (UMLS CUI)
C1977399 (UMLS CUI)
MTHU026517 (LNC)
ExclusionCriterion_6
Item
Hepatic impairment(*) evidenced by the following baseline laboratory findings: - AST or ALT >5X upper limit of normal (ULN) or total bilirubin >3.5X ULN or - AST or ALT >2.5X ULN and total bilirubin >2X ULN (*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.
boolean
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
MTHU004883 (LNC)
C0364055 (UMLS CUI)
1920-8 (LNC)
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
MTHU006766 (LNC)
C0363876 (UMLS CUI)
1742-6 (LNC)
C0857545 (UMLS CUI)
10005368 (MDR)
C0364108 (UMLS CUI)
1975-2 (LNC)
Item Group
Medical Concepts
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
AIDS PATIENT
Item
AIDS PATIENT
string
C0238607 (UMLS CUI)
Antiretroviral therapy
Item
Antiretroviral therapy
string
C1963724 (UMLS CUI)
MTHU000163 (LNC)
10067326 (MDR)
Proteinase inhibitor
Item
Proteinase inhibitor
string
C1961133 (UMLS CUI)
425824001 (SNOMED CT 2010_0731)
Anti-HIV Therapy
Item
Anti-HIV Therapy
string
C1510425 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Contraceptive methods
Item
Contraceptive methods
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Drug Allergy
Item
Drug Allergy
string
C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
Tipranavir
Item
Tipranavir
string
C0663733 (UMLS CUI)
MTHU019174 (LNC)
419409009 (SNOMED CT 2010_0731)
Ritonavir
Item
Ritonavir
string
C0292818 (UMLS CUI)
MTHU013855 (LNC)
386896009 (SNOMED CT 2010_0731)
Restriction
Item
Restriction
string
CL357089 (UMLS CUI)
Pharmaceutical Preparations
Item
Pharmaceutical Preparations
string
C0013227 (UMLS CUI)
MTHU008870 (LNC)
410942007 (SNOMED CT 2010_0731)
Positive Pregnancy Test
Item
Positive Pregnancy Test
string
C0240802 (UMLS CUI)
10036575 (MDR)
250423000 (SNOMED CT 2010_0731)
Breast Feeding
Item
Breast Feeding
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
Investigator
Item
Investigator
string
CL102947 (UMLS CUI)
Investigational New Drug
Item
Investigational New Drug
string
C0013230 (UMLS CUI)
Tipranavir+Ritonavir
Item
Tipranavir+Ritonavir
string
C1977399 (UMLS CUI)
MTHU026517 (LNC)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Aspartate Transaminase
Item
Aspartate Transaminase
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
MTHU004883 (LNC)
Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn
Item
Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn
string
C0364055 (UMLS CUI)
1920-8 (LNC)
Alanine Transaminase
Item
Alanine Transaminase
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
MTHU006766 (LNC)
Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn
Item
Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn
string
C0363876 (UMLS CUI)
1742-6 (LNC)
Blood bilirubin total
Item
Blood bilirubin total
string
C0857545 (UMLS CUI)
10005368 (MDR)
Bilirubin:MCnc:Pt:Ser/Plas:Qn
Item
Bilirubin:MCnc:Pt:Ser/Plas:Qn
string
C0364108 (UMLS CUI)
1975-2 (LNC)
Terug naar het begin van de pagina 

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