Informações:
Falhas:
ID
4575
Descrição
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.
Palavras-chave
Versões (1)
- 11/12/2013 11/12/2013 - Martin Dugas
Transferido a
11 de dezembro de 2013
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00144287 # HIV-1 Infection
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
MTHU000163 (LNC)
10067326 (MDR)
Proteinase inhibitor
Item
Proteinase inhibitor
string
C1961133 (UMLS CUI)
425824001 (SNOMED CT 2010_0731)
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)
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)
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)
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)
MTHU019174 (LNC)
419409009 (SNOMED CT 2010_0731)
Ritonavir
Item
Ritonavir
string
C0292818 (UMLS CUI)
MTHU013855 (LNC)
386896009 (SNOMED CT 2010_0731)
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)
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)
10036575 (MDR)
250423000 (SNOMED CT 2010_0731)
Breast Feeding
Item
Breast Feeding
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
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)
MTHU026517 (LNC)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Aspartate Transaminase
Item
Aspartate Transaminase
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
MTHU004883 (LNC)
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)
1920-8 (LNC)
Alanine Transaminase
Item
Alanine Transaminase
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
MTHU006766 (LNC)
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)
1742-6 (LNC)
Blood bilirubin total
Item
Blood bilirubin total
string
C0857545 (UMLS CUI)
10005368 (MDR)
10005368 (MDR)
Bilirubin:MCnc:Pt:Ser/Plas:Qn
Item
Bilirubin:MCnc:Pt:Ser/Plas:Qn
string
C0364108 (UMLS CUI)
1975-2 (LNC)
1975-2 (LNC)