Informações:
Falhas:
ID
39644
Descrição
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
Palavras-chave
Versões (1)
- 07/02/2020 07/02/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
7 de fevereiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01565889
Eligibility Hepatitis C NCT01565889
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT01565889
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
C0524910 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])