ID

42558

Description

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001); ODM derived from: https://clinicaltrials.gov/show/NCT00192660

Link

https://clinicaltrials.gov/show/NCT00192660

Keywords

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

September 2, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility HIV-Associated Lipodystrophy Syndrome NCT00192660

English

Eligibility HIV-Associated Lipodystrophy Syndrome NCT00192660

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 positive at time of entry to the study.
Description

HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0920548
specific to hiv infection and metabolic abnormalities protocol 1 (hama) part a only:
Description

HIV Infections | Abnormality of metabolism | Clinical Trial Part

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C4021768
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0449719
be naive to antiretroviral medication.
Description

Therapy naive Anti-Retroviral Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0599685
specific to hama part b only:
Description

HIV Infections | Abnormality of metabolism | Clinical Trial Part

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C4021768
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0449719
have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
Description

Anti-Retroviral Agents Exposure to Duration Total Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C0599685
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C0439810
UMLS CUI [1,5]
C1524031
have had a minimum of 48 weeks interval since completion of hama part a.
Description

Interval Since Clinical Trial Part Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0449719
UMLS CUI [1,5]
C0205197
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
prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
Description

Growth Hormone | Glucocorticoids | Anabolic steroids

Data type

boolean

Alias
UMLS CUI [1]
C0037663
UMLS CUI [2]
C0017710
UMLS CUI [3]
C0002845
prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
Description

Testosterone Dose Very high | Estrogen Replacement Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442804
UMLS CUI [2]
C0014935
alcohol or substance abuse which in the opinion of the investigator would affect the patients 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 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 or concomitant use of medications, 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

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
any grade-three 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
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
specific to hama part a only:
Description

HIV Infections | Abnormality of metabolism | Clinical Trial Part

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C4021768
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0449719
prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
Description

Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Antiretroviral therapy | 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]
C1963724
UMLS CUI [8]
C1443861
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Similar models

Eligibility HIV-Associated Lipodystrophy Syndrome NCT00192660

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 positive
Item
hiv antibody positive at time of entry to the study.
boolean
C0920548 (UMLS CUI [1])
HIV Infections | Abnormality of metabolism | Clinical Trial Part
Item
specific to hiv infection and metabolic abnormalities protocol 1 (hama) part a only:
boolean
C0019693 (UMLS CUI [1])
C4021768 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0449719 (UMLS CUI [3,2])
Therapy naive Anti-Retroviral Agents
Item
be naive to antiretroviral medication.
boolean
C0919936 (UMLS CUI [1,1])
C0599685 (UMLS CUI [1,2])
HIV Infections | Abnormality of metabolism | Clinical Trial Part
Item
specific to hama part b only:
boolean
C0019693 (UMLS CUI [1])
C4021768 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0449719 (UMLS CUI [3,2])
Anti-Retroviral Agents Exposure to Duration Total Minimum
Item
have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
boolean
C0599685 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,4])
C1524031 (UMLS CUI [1,5])
Interval Since Clinical Trial Part Completion
Item
have had a minimum of 48 weeks interval since completion of hama part a.
boolean
C1272706 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,4])
C0205197 (UMLS CUI [1,5])
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])
Growth Hormone | Glucocorticoids | Anabolic steroids
Item
prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
boolean
C0037663 (UMLS CUI [1])
C0017710 (UMLS CUI [2])
C0002845 (UMLS CUI [3])
Testosterone Dose Very high | Estrogen Replacement Therapy
Item
prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
boolean
C0039601 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442804 (UMLS CUI [1,3])
C0014935 (UMLS CUI [2])
Substance Use Disorders Study Subject Participation Status Limited
Item
alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
boolean
C0038586 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
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])
Pharmaceutical Preparations Affecting Protocol Compliance
Item
previous or concomitant use of medications, 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])
Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited
Item
any grade-three 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])
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])
HIV Infections | Abnormality of metabolism | Clinical Trial Part
Item
specific to hama part a only:
boolean
C0019693 (UMLS CUI [1])
C4021768 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0449719 (UMLS CUI [3,2])
Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Antiretroviral therapy | 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). entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
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])
C1963724 (UMLS CUI [7])
C1443861 (UMLS CUI [8])
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