ID

39891

Beschrijving

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.; ODM derived from: https://clinicaltrials.gov/show/NCT01258439

Link

https://clinicaltrials.gov/show/NCT01258439

Trefwoorden

Versies (1)
  1. 29-02-20 29-02-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility HIV NCT01258439

Engels

Eligibility HIV NCT01258439

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT01258439
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of signed, informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
age >18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hiv infection documented by hiv antibody test and western blot prior to study entry
Beschrijving

HIV Infections | HIV Antibody Measurement | Western blot for HIV

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C3714540
UMLS CUI [3]
C0860963
no previous art or no art for 6 months prior to randomisation
Beschrijving

Antiretroviral therapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0332197
cd4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
Beschrijving

CD4+ Count | Viral load measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0243009
UMLS CUI [2]
C1261478
no genotypic resistance to raltegravir, tenofovir/emtricitabine, darunavir, ritonavir
Beschrijving

Absence Resistance Genotypic Raltegravir | Absence Resistance Genotypic Tenofovir | Absence Resistance Genotypic Emtricitabine | Absence Resistance Genotypic Darunavir | Absence Resistance Genotypic Ritonavir

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514892
UMLS CUI [1,3]
C0017431
UMLS CUI [1,4]
C1871526
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1514892
UMLS CUI [2,3]
C0017431
UMLS CUI [2,4]
C0384228
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1514892
UMLS CUI [3,3]
C0017431
UMLS CUI [3,4]
C0909839
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1514892
UMLS CUI [4,3]
C0017431
UMLS CUI [4,4]
C1435444
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C1514892
UMLS CUI [5,3]
C0017431
UMLS CUI [5,4]
C0292818
body mass index less than 30kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary hiv infection within the last 6 months
Beschrijving

Primary HIV infection Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1142553
UMLS CUI [1,2]
C0332185
active infection or opportunistic illness within the previous 30 days
Beschrijving

Communicable Disease Recent | Opportunistic Infection Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0029118
UMLS CUI [2,2]
C0332185
use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
Beschrijving

Pharmaceutical Preparation Contraindicated Darunavir+Ritonavir | Pharmaceutical Preparation Contraindicated Raltegravir

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C1976853
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C1871526
use of lipid-lowering therapy
Beschrijving

Lipid-lowering therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0585943
diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
Beschrijving

Diabetes Mellitus | Glucose measurement, fasting

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202045
use of oral prednisolone > 7.5mg daily or equivalent
Beschrijving

Oral prednisolone U/day | Equivalent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0358513
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0205163
pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
proven hypersensitivity to one or more components of the study meal
Beschrijving

Hypersensitivity Component Study Meal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0008972
UMLS CUI [1,4]
C1998602
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Similar models

Eligibility HIV NCT01258439

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT01258439
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of signed, informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
HIV Infections | HIV Antibody Measurement | Western blot for HIV
Item
hiv infection documented by hiv antibody test and western blot prior to study entry
boolean
C0019693 (UMLS CUI [1])
C3714540 (UMLS CUI [2])
C0860963 (UMLS CUI [3])
Antiretroviral therapy Absent
Item
no previous art or no art for 6 months prior to randomisation
boolean
C1963724 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
CD4+ Count | Viral load measurement
Item
cd4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
boolean
C0243009 (UMLS CUI [1])
C1261478 (UMLS CUI [2])
Absence Resistance Genotypic Raltegravir | Absence Resistance Genotypic Tenofovir | Absence Resistance Genotypic Emtricitabine | Absence Resistance Genotypic Darunavir | Absence Resistance Genotypic Ritonavir
Item
no genotypic resistance to raltegravir, tenofovir/emtricitabine, darunavir, ritonavir
boolean
C0332197 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C0017431 (UMLS CUI [1,3])
C1871526 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C1514892 (UMLS CUI [2,2])
C0017431 (UMLS CUI [2,3])
C0384228 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C1514892 (UMLS CUI [3,2])
C0017431 (UMLS CUI [3,3])
C0909839 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C1514892 (UMLS CUI [4,2])
C0017431 (UMLS CUI [4,3])
C1435444 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C1514892 (UMLS CUI [5,2])
C0017431 (UMLS CUI [5,3])
C0292818 (UMLS CUI [5,4])
Body mass index
Item
body mass index less than 30kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Primary HIV infection Recent
Item
primary hiv infection within the last 6 months
boolean
C1142553 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Communicable Disease Recent | Opportunistic Infection Recent
Item
active infection or opportunistic illness within the previous 30 days
boolean
C0009450 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0029118 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Pharmaceutical Preparation Contraindicated Darunavir+Ritonavir | Pharmaceutical Preparation Contraindicated Raltegravir
Item
use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C1976853 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C1871526 (UMLS CUI [2,3])
Lipid-lowering therapy
Item
use of lipid-lowering therapy
boolean
C0585943 (UMLS CUI [1])
Diabetes Mellitus | Glucose measurement, fasting
Item
diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
boolean
C0011849 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
Oral prednisolone U/day | Equivalent
Item
use of oral prednisolone > 7.5mg daily or equivalent
boolean
C0358513 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Component Study Meal
Item
proven hypersensitivity to one or more components of the study meal
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C1998602 (UMLS CUI [1,4])
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