ID

4575

Description

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.

Keywords

Versions (1)
  1. 12/11/13 12/11/13 - Martin Dugas
Uploaded on

December 11, 2013

DOI

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License

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

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

No Healthy Volunteers
Description

Healthy Volunteers

Data type

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
Description

InclusionCriterion_1

Data type

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
Description

InclusionCriterion_2

Data type

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
Description

InclusionCriterion_3

Data type

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
Description

InclusionCriterion_4

Data type

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Description

Exclusion criteria

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

ExclusionCriterion_1

Data type

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
Description

ExclusionCriterion_2

Data type

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.
Description

ExclusionCriterion_3

Data type

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.
Description

ExclusionCriterion_4

Data type

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.
Description

ExclusionCriterion_5

Data type

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.
Description

ExclusionCriterion_6

Data type

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
Description

Medical Concepts

Healthy Subject
Description

Healthy Subject

Data type

string

Alias
UMLS CUI
C1708335
AIDS PATIENT
Description

AIDS PATIENT

Data type

string

Alias
UMLS CUI
C0238607
Antiretroviral therapy
Description

Antiretroviral therapy

Data type

string

Alias
UMLS CUI
C1963724
LNC
MTHU000163
MDR
10067326
Proteinase inhibitor
Description

Proteinase inhibitor

Data type

string

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

Anti-HIV Therapy

Data type

string

Alias
UMLS CUI
C1510425
Age
Description

Age

Data type

string

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

Contraceptive methods

Data type

string

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

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Drug Allergy
Description

Drug Allergy

Data type

string

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

Tipranavir

Data type

string

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

Ritonavir

Data type

string

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

Restriction

Data type

string

Alias
UMLS CUI
CL357089
Pharmaceutical Preparations
Description

Pharmaceutical Preparations

Data type

string

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

Positive Pregnancy Test

Data type

string

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

Breast Feeding

Data type

string

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

Investigator

Data type

string

Alias
UMLS CUI
CL102947
Investigational New Drug
Description

Investigational New Drug

Data type

string

Alias
UMLS CUI
C0013230
Tipranavir+Ritonavir
Description

Tipranavir+Ritonavir

Data type

string

Alias
UMLS CUI
C1977399
LNC
MTHU026517
Liver Dysfunction
Description

Liver Dysfunction

Data type

string

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

Aspartate Transaminase

Data type

string

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

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

Data type

string

Alias
UMLS CUI
C0364055
LNC
1920-8
Alanine Transaminase
Description

Alanine Transaminase

Data type

string

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

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

Data type

string

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

Blood bilirubin total

Data type

string

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

Bilirubin:MCnc:Pt:Ser/Plas:Qn

Data type

string

Alias
UMLS CUI
C0364108
LNC
1975-2
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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