ID

39644

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01565889

Trefwoorden

Versies (1)
  1. 07-02-20 07-02-20 -
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See clinicaltrials.gov

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7 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01565889

Engels

Eligibility Hepatitis C NCT01565889

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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
Beschrijving

Hepatitis C, Chronic

Datatype

boolean

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

HIV-1 infection chronic

Datatype

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
Beschrijving

HIV Antiretroviral therapy Stable | HIV RNA undetectable

Datatype

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
Beschrijving

Contraceptive methods Quantity

Datatype

boolean

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

Therapy naive Chronic Hepatitis C

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected cirrhosis
Beschrijving

Liver Cirrhosis | Liver Cirrhosis Suspected

Datatype

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
Beschrijving

Chronic liver disease Other

Datatype

boolean

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

Medical History Consistent with Decompensated liver disease

Datatype

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
Beschrijving

Illicit medication use

Datatype

boolean

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

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Datatype

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)
Beschrijving

Medical contraindication PEGINTERFERON Therapy | Medical contraindication Ribavirin Therapy

Datatype

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
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Hepatitis C NCT01565889

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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