ID

29844

Descripción

Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00879047

Link

https://clinicaltrials.gov/show/NCT00879047

Palabras clave

Versiones (1)
  1. 23/4/18 23/4/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de abril de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility HIV Infections NCT00879047

Inglés

Eligibility HIV Infections NCT00879047

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants will be diagnosed with hiv/aids, hiv/aids and hepatitis c, mild hepatitis c or will be healthy as determined by history and physical examination, screening laboratory tests and urinalysis, and will be eligible for treatment with haart
Descripción

HIV Infection | AIDS | Hepatitis C | Hepatitis C Mild | Healthy | Medical History | Physical Examination | Laboratory Procedures | Urinalysis | Eligibility HAART

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C2945599
UMLS CUI [5]
C3898900
UMLS CUI [6]
C0262926
UMLS CUI [7]
C0031809
UMLS CUI [8]
C0022885
UMLS CUI [9]
C0042014
UMLS CUI [10,1]
C1548635
UMLS CUI [10,2]
C0887947
participants will be experienced with alcohol consumption
Descripción

Alcohol consumption

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001948
they may meet diagnostic criteria for alcohol abuse or non-physiological alcohol dependence, but may not be dependent on any other substances including opioids, stimulants, cannabis, hallucinogens or other substances, prescribed or illicit
Descripción

Alcohol abuse | Alcoholic Intoxication, Chronic | Opiate Addiction Absent | Stimulant dependence Absent | Cannabis Dependence Absent | Hallucinogen dependence Absent | Other Substance Dependence Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0001973
UMLS CUI [3,1]
C0524662
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C2711618
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0006870
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0018528
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0236933
UMLS CUI [7,2]
C0332197
for those with hcv coinfection, hcv must be at a stage consistent with no more than mild liver fibrosis (fibrosis stage assessed by two methods: the ast to platelet ratio (apri) (at a score of <0.5 for eligibility) and the fib-4 fibrosis index (score of <1.5 for eligibility), both of which indicate mild liver disease.)
Descripción

HCV coinfection | Hepatitis C Consistent with Mild Liver fibrosis | Fibrosis stage Assessment | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C4227681
UMLS CUI [3,1]
C1954435
UMLS CUI [3,2]
C1516048
UMLS CUI [4]
C3846158
age 21 or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
hemoglobin men > 11 g/dl, women > 10 g/dl5
Descripción

Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
able to give voluntary, signed, informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are receiving concurrently other drugs that are inducers or inhibitors of hepatic microsomal enzymes
Descripción

Pharmaceutical Preparations Inducing Microsomal enzymes Hepatic | Microsomal enzymes Hepatic Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0815014
UMLS CUI [1,4]
C0205054
UMLS CUI [2,1]
C0815014
UMLS CUI [2,2]
C0205054
UMLS CUI [2,3]
C0243077
patients with a known sensitivity to the hiv therapeutics to be studied
Descripción

Hypersensitivity Anti-HIV Agents Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0376565
UMLS CUI [1,3]
C1517586
pregnant women or nursing mothers.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
all women who are sexually active and capable of becoming pregnant must have a negative pregnancy test within one week prior to entry into these studies.
Descripción

Childbearing Potential Sexually active Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0427780
major psychotic illness or suicidality.
Descripción

Psychotic illness Major | Suicidality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1860474
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C3166387
clinically active hepatitis with liver enzyme elevations > 3 times the upper limit of normal or evidence of liver fibrosis at a stage indicative of greater than mild stage for fibrosis (see inclusion criteria).
Descripción

Hepatitis | Elevated liver enzymes | Liver Fibrosis Moderate | Liver Fibrosis Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0235996
UMLS CUI [3,1]
C0239946
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0239946
UMLS CUI [4,2]
C0205082
those with obesity (bmi > 30), diabetes, hyperlipidemia, coagulation disorders, or renal disease will be excluded.
Descripción

Obesity | Body mass index | Diabetes Mellitus | Hyperlipidemia | Blood Coagulation Disorders | Kidney Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0020473
UMLS CUI [5]
C0005779
UMLS CUI [6]
C0022658
hemoglobin men < 11 g/dl, women < 10 g/dl
Descripción

Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
physical dependence on alcohol.
Descripción

Alcoholic Intoxication, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
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Similar models

Eligibility HIV Infections NCT00879047

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
HIV Infection | AIDS | Hepatitis C | Hepatitis C Mild | Healthy | Medical History | Physical Examination | Laboratory Procedures | Urinalysis | Eligibility HAART
Item
participants will be diagnosed with hiv/aids, hiv/aids and hepatitis c, mild hepatitis c or will be healthy as determined by history and physical examination, screening laboratory tests and urinalysis, and will be eligible for treatment with haart
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019196 (UMLS CUI [4,1])
C2945599 (UMLS CUI [4,2])
C3898900 (UMLS CUI [5])
C0262926 (UMLS CUI [6])
C0031809 (UMLS CUI [7])
C0022885 (UMLS CUI [8])
C0042014 (UMLS CUI [9])
C1548635 (UMLS CUI [10,1])
C0887947 (UMLS CUI [10,2])
Alcohol consumption
Item
participants will be experienced with alcohol consumption
boolean
C0001948 (UMLS CUI [1])
Alcohol abuse | Alcoholic Intoxication, Chronic | Opiate Addiction Absent | Stimulant dependence Absent | Cannabis Dependence Absent | Hallucinogen dependence Absent | Other Substance Dependence Absent
Item
they may meet diagnostic criteria for alcohol abuse or non-physiological alcohol dependence, but may not be dependent on any other substances including opioids, stimulants, cannabis, hallucinogens or other substances, prescribed or illicit
boolean
C0085762 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0524662 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2711618 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0006870 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0018528 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0236933 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
HCV coinfection | Hepatitis C Consistent with Mild Liver fibrosis | Fibrosis stage Assessment | Other Coding
Item
for those with hcv coinfection, hcv must be at a stage consistent with no more than mild liver fibrosis (fibrosis stage assessed by two methods: the ast to platelet ratio (apri) (at a score of <0.5 for eligibility) and the fib-4 fibrosis index (score of <1.5 for eligibility), both of which indicate mild liver disease.)
boolean
C1698259 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C4227681 (UMLS CUI [2,3])
C1954435 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
Age
Item
age 21 or older
boolean
C0001779 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hemoglobin men > 11 g/dl, women > 10 g/dl5
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Informed Consent
Item
able to give voluntary, signed, informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Inducing Microsomal enzymes Hepatic | Microsomal enzymes Hepatic Inhibitors
Item
patients who are receiving concurrently other drugs that are inducers or inhibitors of hepatic microsomal enzymes
boolean
C0013227 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0815014 (UMLS CUI [1,3])
C0205054 (UMLS CUI [1,4])
C0815014 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0243077 (UMLS CUI [2,3])
Hypersensitivity Anti-HIV Agents Investigational
Item
patients with a known sensitivity to the hiv therapeutics to be studied
boolean
C0020517 (UMLS CUI [1,1])
C0376565 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant women or nursing mothers.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Sexually active Pregnancy test negative
Item
all women who are sexually active and capable of becoming pregnant must have a negative pregnancy test within one week prior to entry into these studies.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Psychotic illness Major | Suicidality
Item
major psychotic illness or suicidality.
boolean
C1860474 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C3166387 (UMLS CUI [2])
Hepatitis | Elevated liver enzymes | Liver Fibrosis Moderate | Liver Fibrosis Severe
Item
clinically active hepatitis with liver enzyme elevations > 3 times the upper limit of normal or evidence of liver fibrosis at a stage indicative of greater than mild stage for fibrosis (see inclusion criteria).
boolean
C0019158 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0239946 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0239946 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Obesity | Body mass index | Diabetes Mellitus | Hyperlipidemia | Blood Coagulation Disorders | Kidney Diseases
Item
those with obesity (bmi > 30), diabetes, hyperlipidemia, coagulation disorders, or renal disease will be excluded.
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0020473 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
Hemoglobin measurement | Gender
Item
hemoglobin men < 11 g/dl, women < 10 g/dl
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Alcoholic Intoxication, Chronic
Item
physical dependence on alcohol.
boolean
C0001973 (UMLS CUI [1])
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