ID

17566

Description

Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00192621

Link

https://clinicaltrials.gov/show/NCT00192621

Keywords

Versions (2)
  1. 9/24/16 9/24/16 -
  2. 9/2/21 9/2/21 -
Uploaded on

September 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility HIV Infections NCT00192621

English

Eligibility HIV Infections NCT00192621

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
be able to provide written consent to perform in the trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
hiv antibody negative and hiv dna negative at time of entry to the study.
Description

HIV antibody negative | Human immunodeficiency virus DNA Negative

Data type

boolean

Alias
UMLS CUI [1]
C1142096
UMLS CUI [2,1]
C0486959
UMLS CUI [2,2]
C1513916
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
Description

Mental disorders Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited | Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
UMLS CUI [3]
C0151744
history of type i or type ii diabetes mellitus or previous treatment with antidiabetic medication.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0935929
prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
Description

Testosterone | Estrogens | Growth Hormone | Glucocorticoids Oral | Anabolic steroids

Data type

boolean

Alias
UMLS CUI [1]
C0039601
UMLS CUI [2]
C0014939
UMLS CUI [3]
C0037663
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0002744
alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
Description

Substance Use Disorders Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
Description

Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Post-Exposure Prophylaxis

Data type

boolean

Alias
UMLS CUI [1]
C0599685
UMLS CUI [2]
C0033607
UMLS CUI [3]
C1373111
UMLS CUI [4]
C1373120
UMLS CUI [5,1]
C0599685
UMLS CUI [5,2]
C1517586
UMLS CUI [6]
C1275666
UMLS CUI [7]
C1443861
prior use of any retinoid-containing compound within the previous six months.
Description

Compound Containing Retinoids

Data type

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0035339
abnormal coagulation.
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
previous allergic reaction or known allergy to local anaesthetic.
Description

Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0002934
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0002934
previous use of psychotropic medications.
Description

Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0033978
concomitant use of medications, including those metabolised by cyp3a4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
Description

Pharmaceutical Preparations Affecting Protocol Compliance | drug metabolism Due to CYP3A4

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0683140
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1142644
any grade-three laboratory abnormality recorded from screening bloods.
Description

Blood Screening LABORATORY ABNORMALITIES Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C1511226
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C0441800
any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
Description

Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1511226
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
gastrointestinal disorders, which may affect drug absorption.
Description

Gastrointestinal Diseases Affecting drug absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
Description

screening examination Finding Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0281974
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
evidence of acute or chronic active hepatitis b virus infection by serology performed at baseline.
Description

Hepatitis B Evidence Serologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
evidence of hepatitis c infection by serology performed at baseline.
Description

Hepatitis C Evidence Serologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
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Similar models

Eligibility HIV Infections NCT00192621

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >18
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
be able to provide written consent to perform in the trial.
boolean
C0021430 (UMLS CUI [1])
HIV antibody negative | Human immunodeficiency virus DNA Negative
Item
hiv antibody negative and hiv dna negative at time of entry to the study.
boolean
C1142096 (UMLS CUI [1])
C0486959 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Mental disorders Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited | Myocardial Ischemia
Item
any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
boolean
C0004936 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0151744 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics
Item
history of type i or type ii diabetes mellitus or previous treatment with antidiabetic medication.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
Testosterone | Estrogens | Growth Hormone | Glucocorticoids Oral | Anabolic steroids
Item
prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
boolean
C0039601 (UMLS CUI [1])
C0014939 (UMLS CUI [2])
C0037663 (UMLS CUI [3])
C0017710 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0002744 (UMLS CUI [5])
Substance Use Disorders Study Subject Participation Status Limited
Item
alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
boolean
C0038586 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Post-Exposure Prophylaxis
Item
prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
boolean
C0599685 (UMLS CUI [1])
C0033607 (UMLS CUI [2])
C1373111 (UMLS CUI [3])
C1373120 (UMLS CUI [4])
C0599685 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C1275666 (UMLS CUI [6])
C1443861 (UMLS CUI [7])
Compound Containing Retinoids
Item
prior use of any retinoid-containing compound within the previous six months.
boolean
C1706082 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0035339 (UMLS CUI [1,3])
Blood Coagulation Disorders
Item
abnormal coagulation.
boolean
C0005779 (UMLS CUI [1])
Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics
Item
previous allergic reaction or known allergy to local anaesthetic.
boolean
C1527304 (UMLS CUI [1,1])
C0002934 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0002934 (UMLS CUI [2,2])
Psychotropic Drugs
Item
previous use of psychotropic medications.
boolean
C0033978 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Protocol Compliance | drug metabolism Due to CYP3A4
Item
concomitant use of medications, including those metabolised by cyp3a4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0683140 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1142644 (UMLS CUI [2,3])
Blood Screening LABORATORY ABNORMALITIES Grade
Item
any grade-three laboratory abnormality recorded from screening bloods.
boolean
C1511226 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited
Item
any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
boolean
C1511226 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Gastrointestinal Diseases Affecting drug absorption
Item
gastrointestinal disorders, which may affect drug absorption.
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
screening examination Finding Study Subject Participation Status Limited
Item
any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
boolean
C0281974 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Hepatitis B Evidence Serologic
Item
evidence of acute or chronic active hepatitis b virus infection by serology performed at baseline.
boolean
C0019163 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
Hepatitis C Evidence Serologic
Item
evidence of hepatitis c infection by serology performed at baseline.
boolean
C0019196 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
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