ID

34329

Description

Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection; ODM derived from: https://clinicaltrials.gov/show/NCT01147107

Link

https://clinicaltrials.gov/show/NCT01147107

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C, Chronic NCT01147107

Eligibility Hepatitis C, Chronic NCT01147107

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hiv infected patients, age >18 years, meet vietnam guideline to begin art (cd4 count < 350 cells/mm3 and/or who stage iii or iv disease)
Description

ID.1

Data type

boolean

hepatitis c infection as documented by positive hcv antibodies and a detectable serum hcv rna level
Description

ID.2

Data type

boolean

ast and alt ≤ 2 x uln (≤ 80 u/l)
Description

ID.3

Data type

boolean

estimated creatinine clearance ≥ 60 ml/min
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior art
Description

ID.5

Data type

boolean

positive hepatitis b surface antigen
Description

ID.6

Data type

boolean

clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
Description

ID.7

Data type

boolean

requirement for acute therapy for other aids-defining illness within 14 days prior to study entry
Description

ID.8

Data type

boolean

currently on rifampicin therapy
Description

ID.9

Data type

boolean

in the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period
Description

ID.10

Data type

boolean

Similar models

Eligibility Hepatitis C, Chronic NCT01147107

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
hiv infected patients, age >18 years, meet vietnam guideline to begin art (cd4 count < 350 cells/mm3 and/or who stage iii or iv disease)
boolean
ID.2
Item
hepatitis c infection as documented by positive hcv antibodies and a detectable serum hcv rna level
boolean
ID.3
Item
ast and alt ≤ 2 x uln (≤ 80 u/l)
boolean
ID.4
Item
estimated creatinine clearance ≥ 60 ml/min
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
any prior art
boolean
ID.6
Item
positive hepatitis b surface antigen
boolean
ID.7
Item
clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
boolean
ID.8
Item
requirement for acute therapy for other aids-defining illness within 14 days prior to study entry
boolean
ID.9
Item
currently on rifampicin therapy
boolean
ID.10
Item
in the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period
boolean

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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