ID

39644

Beskrivning

Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT01565889

Länk

https://clinicaltrials.gov/show/NCT01565889

Nyckelord

Versioner (1)
  1. 2020-02-07 2020-02-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 februari 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatitis C NCT01565889

Engelsk

Eligibility Hepatitis C NCT01565889

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy according to medical history and physical examination with exception of hcv and hiv diagnoses
Beskrivning

Healthy Medical History | Healthy Physical Examination | Exception Hepatitis C | Exception HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0019693
confirmation of chronic hcv infection
Beskrivning

Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
confirmation of chronic hiv-1 infection
Beskrivning

HIV-1 infection chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2363741
UMLS CUI [1,2]
C0205191
on a stable protocol approved hiv antiretroviral (arv) regimen with undetectable hiv-rna
Beskrivning

HIV Antiretroviral therapy Stable | HIV RNA undetectable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C1963724
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0877598
agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Beskrivning

Contraceptive methods Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
subjects must be naive to treatment for chronic hcv infection
Beskrivning

Therapy naive Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0524910
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected cirrhosis
Beskrivning

Liver Cirrhosis | Liver Cirrhosis Suspected

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0750491
history of any other clinically significant chronic liver disease
Beskrivning

Chronic liver disease Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0205394
a history consistent with decompensated liver disease.
Beskrivning

Medical History Consistent with Decompensated liver disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C4075847
use of any prohibited medications as defined by the protocol
Beskrivning

Illicit medication use

Datatyp

boolean

Alias
UMLS CUI [1]
C0281875
pregnant or nursing female or male with pregnant female partner
Beskrivning

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
contraindication to peg or rbv therapy (for part b)
Beskrivning

Medical contraindication PEGINTERFERON Therapy | Medical contraindication Ribavirin Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0982327
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0035525
UMLS CUI [2,3]
C0087111
clinically relevant drug or alcohol abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
Tillbaka till toppen

Similar models

Eligibility Hepatitis C NCT01565889

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Medical History | Healthy Physical Examination | Exception Hepatitis C | Exception HIV Infection
Item
healthy according to medical history and physical examination with exception of hcv and hiv diagnoses
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019693 (UMLS CUI [4,2])
Hepatitis C, Chronic
Item
confirmation of chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
HIV-1 infection chronic
Item
confirmation of chronic hiv-1 infection
boolean
C2363741 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
HIV Antiretroviral therapy Stable | HIV RNA undetectable
Item
on a stable protocol approved hiv antiretroviral (arv) regimen with undetectable hiv-rna
boolean
C0019682 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0877598 (UMLS CUI [2])
Contraceptive methods Quantity
Item
agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Therapy naive Chronic Hepatitis C
Item
subjects must be naive to treatment for chronic hcv infection
boolean
C0919936 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis | Liver Cirrhosis Suspected
Item
known or suspected cirrhosis
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Chronic liver disease Other
Item
history of any other clinically significant chronic liver disease
boolean
C0341439 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Medical History Consistent with Decompensated liver disease
Item
a history consistent with decompensated liver disease.
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C4075847 (UMLS CUI [1,3])
Illicit medication use
Item
use of any prohibited medications as defined by the protocol
boolean
C0281875 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or nursing female or male with pregnant female partner
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Medical contraindication PEGINTERFERON Therapy | Medical contraindication Ribavirin Therapy
Item
contraindication to peg or rbv therapy (for part b)
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Substance Use Disorders
Item
clinically relevant drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial