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Description

AMC-061 Enrollment Form (ENR) Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Mots-clés

Versions (3)
  1. 26/08/2012 26/08/2012 -
  2. 08/07/2015 08/07/2015 -
  3. 08/07/2015 08/07/2015 -
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26 août 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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    Brain and Central Nervous System Tumors NCT00890747 Registration - AMC-061 Enrollment Form (ENR) - 2913694v1.0

    Anglais

    No Instruction available.

    1 Formulaires  
    1. StudyEvent: AMC-061 Enrollment Form (ENR)
      1. No Instruction available.
    Unnamed1
    Description

    Unnamed1

    Projected Start Date of Treatment (mm/dd/yyyy)
    Description

    TreatmentProjectedBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus ObjectClass
    C25631 (undefined)
    NCI Thesaurus Property
    C25431 (undefined)
    UMLS 2011AA Property
    C0439659 (Beginning)
    SNOMED
    255395001
    LOINC
    LP21371-7
    NCI Thesaurus Property
    C25275 (undefined)
    UMLS 2011AA Property
    C2745955 (Occurrence)
    SNOMED
    246454002
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus ValueDomain
    C25431 (undefined)
    UMLS 2011AA ValueDomain
    C0439659 (Beginning)
    SNOMED
    255395001
    LOINC
    LP21371-7
    Inclusion/exclusion Criteria
    Description

    Inclusion/exclusion Criteria

    Inclusion Criteria
    Description

    AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria061Type

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus ObjectClass
    C19707 (undefined)
    UMLS 2011AA ObjectClass
    C1515830 (AIDS Malignancy Consortium)
    NCI Thesaurus Property
    C16112 (undefined)
    UMLS 2011AA Property
    C1516637 (Clinical Trial Eligibility Criteria)
    NCI Thesaurus Property
    C25532 (undefined)
    UMLS 2011AA Property
    C1512693 (Inclusion)
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Exclusion Criteria
    Description

    Exclusion Criteria

    Exclusion Criteria
    Description

    AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria061Type

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus ObjectClass
    C19707 (undefined)
    UMLS 2011AA ObjectClass
    C1515830 (AIDS Malignancy Consortium)
    NCI Thesaurus Property
    C16112 (undefined)
    UMLS 2011AA Property
    C1516637 (Clinical Trial Eligibility Criteria)
    NCI Thesaurus Property
    C25370 (undefined)
    UMLS 2011AA Property
    C0680251 (Exclusion Criteria)
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Exclusion Criteria
    Description

    Exclusion Criteria

    Type of Cancer
    Description

    CancerSiteType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    NCI Thesaurus Property
    C25341 (undefined)
    UMLS 2011AA Property
    C0450429 (Location)
    SNOMED
    246267002
    LOINC
    LP149876-7
    NCI Thesaurus ObjectClass
    C9305 (undefined)
    UMLS 2011AA ObjectClass
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    HAART regimen type
    Description

    PatientHighlyActiveAntiretroviralTherapyRegimenType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus Property
    C16165 (undefined)
    UMLS 2011AA Property
    C0887947 (Antiretroviral Therapy, Highly Active)
    SNOMED
    416234007
    NCI Thesaurus Property
    C15697 (undefined)
    UMLS 2011AA Property
    C0040808 (Treatment Protocols)
    Karnofsky Performance Status (must be > 60%)
    Description

    KarnofskyPerformanceStatusScore

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C25367 (undefined)
    NCI Thesaurus ObjectClass
    C20641 (undefined)
    UMLS 2011AA ObjectClass
    C1518965 (Performance Status)
    NCI Thesaurus ValueDomain
    C25338 (undefined)
    UMLS 2011AA ValueDomain
    C0449820 (Score)
    SNOMED
    246262008
    LOINC
    MTHU024701
    Age (in years)
    Description

    PatientAgeYearCount

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus ValueDomain
    C29848 (undefined)
    UMLS 2011AA ValueDomain
    C0439234 (year)
    SNOMED
    258707000
    NCI Thesaurus ValueDomain
    C25463 (undefined)
    UMLS 2011AA ValueDomain
    C0750480 (Count)
    NCI Thesaurus Property
    C25150 (undefined)
    UMLS 2011AA Property
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Date Informed Consent Signed (mm/dd/yyyy)
    Description

    InformedConsentFormSignedDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus ValueDomain
    C25367 (undefined)
    NCI Thesaurus ObjectClass
    C16468 (undefined)
    UMLS 2011AA ObjectClass
    C0009797 (Consent Forms)
    NCI Thesaurus Property
    C25679 (undefined)
    Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
    Description

    Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens

    Does the participant agree to participate in the pharmacogenetics study associated with this protocol
    Description

    SpecimenRelatedGeneticResearchConsentInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C19157 (undefined)
    UMLS 2011AA ObjectClass
    C0370003 (Specimen)
    SNOMED
    123038009
    LOINC
    LP7593-9
    NCI Thesaurus Property
    C15319 (undefined)
    NCI Thesaurus Property
    C25648 (undefined)
    UMLS 2011AA Property
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    NCI Thesaurus Property
    C17938 (undefined)
    UMLS 2011AA Property
    C0314603 (Genetic)
    LOINC
    LP247965-9
    NCI Thesaurus Property
    C25460 (undefined)
    UMLS 2011AA Property
    C1511481 (Consent)
    LOINC
    LP100037-3
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS 2011AA ValueDomain
    C1512698 (Yes or No Response)
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    Description

    BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C12801 (undefined)
    UMLS 2011AA ObjectClass
    C0040300 (Body tissue)
    SNOMED
    85756007
    LOINC
    LP7641-6
    NCI Thesaurus ObjectClass
    C12434 (undefined)
    UMLS 2011AA ObjectClass
    C0229664 (peripheral blood)
    SNOMED
    119273009
    NCI Thesaurus ObjectClass
    C19157 (undefined)
    UMLS 2011AA ObjectClass
    C0370003 (Specimen)
    SNOMED
    123038009
    LOINC
    LP7593-9
    NCI Thesaurus Property
    C17649 (undefined)
    UMLS 2011AA Property
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    NCI Thesaurus Property
    C15319 (undefined)
    NCI Thesaurus Property
    C67527 (undefined)
    UMLS 2011AA Property
    C0016884 (Future)
    NCI Thesaurus Property
    C2991 (undefined)
    UMLS 2011AA Property
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    NCI Thesaurus Property
    C25460 (undefined)
    UMLS 2011AA Property
    C1511481 (Consent)
    LOINC
    LP100037-3
    NCI Thesaurus ValueDomain
    C38147 (undefined)
    UMLS 2011AA ValueDomain
    C1512698 (Yes or No Response)
    Comments
    Description

    Comments

    Comments
    Description

    ResearchCommentsText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS 2011AA ValueDomain
    C1527021 (Text)
    LOINC
    LP6885-0
    NCI Thesaurus ObjectClass
    C15319 (undefined)
    NCI Thesaurus Property
    C25393 (undefined)
    UMLS 2011AA Property
    C0282411 (Published Comment)
    LOINC
    MTHU018874
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    No Instruction available.

    1 Formulaires
    1. StudyEvent: AMC-061 Enrollment Form (ENR)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Unnamed1
    TreatmentProjectedBeginDate
    Item
    Projected Start Date of Treatment (mm/dd/yyyy)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    Item Group
    Inclusion/exclusion Criteria
    Item
    Inclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19707 (NCI Thesaurus ObjectClass)
    C1515830 (UMLS 2011AA ObjectClass)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25532 (NCI Thesaurus Property)
    C1512693 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.1
    Code List
    Inclusion Criteria
    CL Item
    Date Informed Consent Obtained (Date informed consent obtained)
    CL Item
    Does The Participant Agree To Employ An Effective Barrier Method Of Birth Control Throughout The Study And For Up To 3 Months Following Discontinuation Of Study Drug (Does the participant agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)
    CL Item
    Does The Participant Have A Cd4 Count > 50 Cells/ul (Does the participant have a CD4 count > 50 cells/uL)
    CL Item
    Does The Participant Have The Following Laboratory Parameters Within 7 Days Prior To Study Entry Hemoglobin >= 8.0 Gm/dl Absolute Neutrophil Count (anc) >= 1500 Cells/mm^3 Platelet Count >= 100,000 /mm^3 (Does the participant have the following laboratory parameters within 7 days prior to study entry Hemoglobin >= 8.0 gm/dL Absolute neutrophil count (ANC) >= 1500 cells/mm^3 Platelet count >= 100,000 /mm^3)
    CL Item
    Creatinine Within Institutional Normal Limits Or Glomerular Filtration Rate (gfr) > 60 Ml/min/m^2 (calculated By The Cockcroft-gault Equation) (Creatinine within institutional normal limits or Glomerular filtration rate (GFR) > 60 mL/min/m^2 (calculated by the Cockcroft-Gault equation))
    CL Item
    Total Bilirubin <= 1.5 Times Uln (upper Limit Of Normal) (if "no") Is The Elevated Bilirubin Felt To Be Secondary To Indinavir Therapy (if "yes") Is Total Bilirubin < 3.5 Mg/dl And Is Direct Bilirubin <= 1.5 Times Uln (Total bilirubin <= 1.5 times ULN (upper limit of normal) (If "No") Is the elevated bilirubin felt to be secondary to Indinavir therapy (If "Yes") Is total bilirubin < 3.5 mg/dL and is direct bilirubin <= 1.5 times ULN)
    CL Item
    (if "no) Is The Elevated Bilirubin Felt To Be Secondary To Atazanavir Therapy (if "yes") Is Direct Bilirubin <= 1.5 Times Uln Ast (sgot) And Alt (sgpt) <= 2.5 Times The Uln ((If "No) Is the elevated bilirubin felt to be secondary to Atazanavir therapy (If "Yes") Is direct bilirubin <= 1.5 times ULN AST (SGOT) and ALT (SGPT) <= 2.5 times the ULN)
    CL Item
    Does The Participant Have A Histologically Or Cytologically Confirmed Nhl, Biopsy-proven Ks Or Solid Tumor Or Hematological Malignancy (Does the participant have a histologically or cytologically confirmed NHL, biopsy-proven KS or solid tumor or hematological malignancy)
    CL Item
    Does The Participant Have Serologic Documentation Of Hiv Infection At Any Time Prior To Study Entry, As Evidenced By Positive Elisa, Positive Western Blot, Or Other Federally Approved Licensed Hiv Test (Does the participant have serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test)
    CL Item
    Does The Participant Have The Ability And Willingness To Give Written Informed Consent (Does the participant have the ability and willingness to give written informed consent)
    CL Item
    If The Participant Is Female, And Of Child-bearing Potential, Has She Had A Negative Pregnancy Test Within 72 Hours Before Initiation Of Study Drug Dosing (If the participant is female, and of child-bearing potential, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing)
    CL Item
    If Yes, Indicate Cancer Type (see Protocol Section 4.0 For Specific Eligibility Criteria) Nhl, Ks, Renal Cell Cancer, Solid Tumor, Hematologic Malignancy (If Yes, indicate cancer type (see protocol section 4.0 for specific eligibility criteria) NHL, KS, Renal Cell Cancer, Solid tumor, Hematologic malignancy)
    CL Item
    Is The Participant On Stable Anti-retroviral Therapy For At Least 4 Weeks With A Pi-based Or Nnrti-based Regimen Of At Least Three Drugs, With No Intention To Change The Regimen Within 8 Weeks After Starting Study Drug (Is the participant on stable anti-retroviral therapy for at least 4 weeks with a PI-based or NNRTI-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks after starting study drug)
    CL Item
    If Yes, Indicate Haart Regimen Type Nnrti-based Only, Non Ritonavir Pi-based Only, Ritonavir Pi-based Only, Nnrti- And Non Ritonavir Pi-based, Nnrti- And Ritonavir Pi-based, Neither Pi Nor Nnrti Based (If Yes, indicate HAART regimen type NNRTI-based only, Non ritonavir PI-based only, Ritonavir PI-based only, NNRTI- and non ritonavir PI-based, NNRTI- and ritonavir PI-based, Neither PI nor NNRTI based)
    CL Item
    Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
    CL Item
    Is The Participant, In The Opinion Of The Investigator, Capable Of Complying With This Protocol (Is the participant, in the opinion of the Investigator, capable of complying with this protocol)
    CL Item
    Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
    CL Item
    Participant's Age (in Years) (Participant's age (in years))
    Item Group
    Exclusion Criteria
    Item
    Exclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19707 (NCI Thesaurus ObjectClass)
    C1515830 (UMLS 2011AA ObjectClass)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25370 (NCI Thesaurus Property)
    C0680251 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.2
    Code List
    Exclusion Criteria
    CL Item
    Does The Participant Have A Concurrent Active Opportunistic Infection (Does the participant have a concurrent active opportunistic infection)
    CL Item
    Does The Participant Have A History Of Serious Ventricular Arrhythmia (ventricular Tachycardia (vt) Or Ventricular Fibrillation (vf) >= 3 Beats In A Row) (Does the participant have a history of serious ventricular arrhythmia (ventricular tachycardia (VT) or ventricular fibrillation (VF) >= 3 beats in a row))
    CL Item
    Does The Participant Have Ongoing Ventricular Cardiac Dysrhythmias Of Nci Ctcae Grade >= 2 (Does the participant have ongoing ventricular cardiac dysrhythmias of NCI CTCAE grade >= 2)
    CL Item
    Does The Participant Have Clinically Significant Cardiovascular Disease, Including Uncontrolled Hypertension (diastolic Blood Pressure >=100 Mmhg Despite Optimal Medical Therapy) Or Unstable Angina (Does the participant have clinically significant cardiovascular disease, including uncontrolled hypertension (diastolic blood pressure >=100 mmHg despite optimal medical therapy) or unstable angina)
    CL Item
    Does The Participant Have A Pre-existing Thyroid Abnormality That Cannot Be Maintained With Medication To Keep Measures Of Thyroid Stimulating Hormone Within The Normal Range (Does the participant have a pre-existing thyroid abnormality that cannot be maintained with medication to keep measures of thyroid stimulating hormone within the normal range)
    CL Item
    Does The Participant Have A Psychiatric Illness That Would Limit Compliance With Study Requirements (Does the participant have a psychiatric illness that would limit compliance with study requirements)
    CL Item
    Does The Participant Have A Qtc Interval > 500 Msec (Does the participant have a QTc interval > 500 msec)
    CL Item
    Does The Participant Have Another Severe And/or Life-threatening Medical Disease (Does the participant have another severe and/or life-threatening medical disease)
    CL Item
    Does The Participant Have Gastrointestinal Tract Disease Resulting In An Inability To Take Oral Medication Or A Requirement For Iv Alimentation, Prior Surgical Procedures Affecting Absorption, Or Active Peptic Ulcer Disease (Does the participant have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
    CL Item
    Does The Participant Have Serious Cardiac Arrhythmia Requiring Medication (Does the participant have serious cardiac arrhythmia requiring medication)
    CL Item
    Has The Participant Had A Myocardial Infarction, Severe/unstable Angina, Coronary Artery Bypass Graft, Cerebrovascular Accident, Transient Ischemic Attack, Or Pulmonary Embolism Within 6 Months Of Study Entry (Has the participant had a myocardial infarction, severe/unstable angina, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of study entry)
    CL Item
    Does The Participant Have An Abnormal Left Ventricular Ejection Fraction Per Institutional Standards (Does the participant have an abnormal Left Ventricular Ejection Fraction per institutional standards)
    CL Item
    Has The Participant Had Acute Treatment For An Infection Or Other Serious Medical Illness Within 14 Days Prior To Study Entry (Has the participant had acute treatment for an infection or other serious medical illness within 14 days prior to study entry)
    CL Item
    Has The Participant Had Major Surgery Or Radiation Within 3 Weeks Prior To Study Entry (Has the participant had major surgery or radiation within 3 weeks prior to study entry)
    CL Item
    Has The Participant Received Antineoplastic Therapy, Including Investigational Drug Or Standard Treatment, Within 2 Weeks Of Study Entry? (must Be Able To Demonstrate Adequate Recovery From Prior Therapy-related Toxicities.) (Has the participant received antineoplastic therapy, including investigational drug or standard treatment, within 2 weeks of study entry? (Must be able to demonstrate adequate recovery from prior therapy-related toxicities.))
    CL Item
    If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
    CL Item
    Will The Participant Undergo Concurrent Treatment With Medications, Other Than Antiretroviral Drugs Used To Treat Hiv Infection, That Are Known To Inhibit Or Induce Cyp3a4 (Will the participant undergo concurrent treatment with medications, other than antiretroviral drugs used to treat HIV infection, that are known to inhibit or induce CYP3A4)
    Item Group
    Exclusion Criteria
    Item
    Type of Cancer
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    CL.3
    Code List
    Type of Cancer
    CL Item
    Non-hodgkin's Lymphoma (Non-Hodgkin's lymphoma)
    C3211 (NCI Thesaurus)
    C0024305 (UMLS 2011AA)
    CL Item
    Kaposi Sarcoma (KS)
    C9087 (NCI Thesaurus)
    C0036220 (UMLS 2011AA)
    CL Item
    Renal Cell Carcinoma (Renal Cell Cancer)
    C9385 (NCI Thesaurus)
    C0007134 (UMLS 2011AA)
    CL Item
    Solid Neoplasm (Solid tumor)
    C9292 (NCI Thesaurus)
    C0280100 (UMLS 2011AA)
    CL Item
    Hematologic Malignancy (Hematologic malignancy)
    Item
    HAART regimen type
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16165 (NCI Thesaurus Property)
    C0887947 (UMLS 2011AA Property)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    CL.4
    Code List
    HAART regimen type
    CL Item
    Nnrti-based Only (NNRTI-based only)
    CL Item
    Non-ritonavir Pi-based Only (Non-ritonavir PI-based only)
    CL Item
    Ritonavir Pi-based Only (Ritonavir PI-based only)
    CL Item
    Nnrti- And Non-ritonavir Pi-based (NNRTI- and non-ritonavir PI-based)
    CL Item
    Nnrti- And Ritonavir Pi-based (NNRTI- and ritonavir PI-based)
    CL Item
    Neither Pi Nor Nnrti Based (Neither PI nor NNRTI based)
    KarnofskyPerformanceStatusScore
    Item
    Karnofsky Performance Status (must be > 60%)
    text
    C25367 (NCI Thesaurus Property)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    PatientAgeYearCount
    Item
    Age (in years)
    double
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS 2011AA Property)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    Item Group
    Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
    Item
    Does the participant agree to participate in the pharmacogenetics study associated with this protocol
    text
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property)
    C0439849 (UMLS 2011AA Property)
    C17938 (NCI Thesaurus Property)
    C0314603 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.5
    Code List
    Does the participant agree to participate in the pharmacogenetics study associated with this protocol
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    text
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C15319 (NCI Thesaurus Property)
    C67527 (NCI Thesaurus Property)
    C0016884 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property)
    C0012634 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Comments
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)
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