ID

39578

Description

Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT02220868

Lien

https://clinicaltrials.gov/show/NCT02220868

Mots-clés

  1. 31/01/2020 31/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

31 janvier 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Hepatitis C Infection NCT02220868

Eligibility Hepatitis C Infection NCT02220868

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
chronic hcv genotype 1 infection
Description

Chronic Hepatitis C Genotype

Type de données

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
Description

Cobicistat and elvitegravir and emtricitabine and tenofovir

Type de données

boolean

Alias
UMLS CUI [1]
C3499879
cd4 count >200 cells/mm3 at screening and no cd4 count <200 in previous 12 weeks
Description

CD4 Count

Type de données

boolean

Alias
UMLS CUI [1]
C0243009
hiv rna pcr <50 copies/ml at screening and no hiv rna pcr > 200 copies/ml in previous 12 weeks
Description

Human Immunodeficiency Virus RNA copies/mL Polymerase Chain Reaction

Type de données

boolean

Alias
UMLS CUI [1,1]
C4330330
UMLS CUI [1,2]
C1531853
UMLS CUI [1,3]
C0032520
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of integrase inhibitor resistance
Description

Integrase Inhibitor Resistance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0376601
UMLS CUI [1,2]
C1514892
history of integrase inhibitor failure
Description

Integrase Inhibitor Failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0376601
UMLS CUI [1,2]
C0231174
absolute neutrophil counts under 1500/mm3 ( black/ african americans <1200/mm3
Description

Absolute neutrophil count | African Americans

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0085756
patients with cirrhosis
Description

Liver Cirrhosis

Type de données

boolean

Alias
UMLS CUI [1]
C0023890
platelet count under 90,000 per cubic millimeter
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
Description

Hemoglobin measurement | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
previous treatment with a daa
Description

DIRECT ACTING ANTIVIRALS

Type de données

boolean

Alias
UMLS CUI [1]
C3653501
hepatocellular carcinoma
Description

Liver carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C2239176
afp>100 ng/ml
Description

Alpha one fetoprotein measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201539
hepatitis b virus (hbsag positive)
Description

Hepatitis B Virus | Hepatitis B surface antigen positive

Type de données

boolean

Alias
UMLS CUI [1]
C0019169
UMLS CUI [2]
C0149709
evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Description

Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Type de données

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151

Similar models

Eligibility Hepatitis C Infection NCT02220868

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
chronic hcv genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Cobicistat and elvitegravir and emtricitabine and tenofovir
Item
receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
boolean
C3499879 (UMLS CUI [1])
CD4 Count
Item
cd4 count >200 cells/mm3 at screening and no cd4 count <200 in previous 12 weeks
boolean
C0243009 (UMLS CUI [1])
Human Immunodeficiency Virus RNA copies/mL Polymerase Chain Reaction
Item
hiv rna pcr <50 copies/ml at screening and no hiv rna pcr > 200 copies/ml in previous 12 weeks
boolean
C4330330 (UMLS CUI [1,1])
C1531853 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Integrase Inhibitor Resistance
Item
history of integrase inhibitor resistance
boolean
C0376601 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
Integrase Inhibitor Failure
Item
history of integrase inhibitor failure
boolean
C0376601 (UMLS CUI [1,1])
C0231174 (UMLS CUI [1,2])
Absolute neutrophil count | African Americans
Item
absolute neutrophil counts under 1500/mm3 ( black/ african americans <1200/mm3
boolean
C0948762 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Liver Cirrhosis
Item
patients with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count under 90,000 per cubic millimeter
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
DIRECT ACTING ANTIVIRALS
Item
previous treatment with a daa
boolean
C3653501 (UMLS CUI [1])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alpha one fetoprotein measurement
Item
afp>100 ng/ml
boolean
C0201539 (UMLS CUI [1])
Hepatitis B Virus | Hepatitis B surface antigen positive
Item
hepatitis b virus (hbsag positive)
boolean
C0019169 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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