Cidofovir HIV (NCT00550589)

AMC-046 Enrollment Form (ENR) Segment B Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus NCT00550589 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BC16E2A-1483-2256-E044-0003BA3F9857

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  1. StudyEvent: AMC-046 Enrollment Form (ENR) Segment B
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PrincipalInvestigatorName
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS CUI-1)
Treatment Begin Date
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-1)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)
Item Group
Inclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C16112 (NCI Thesaurus Property)
C25532 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C1512693 (UMLS CUI-1)
Code List
Inclusion Criteria
CL Item
Will The Participant Practice Adequate Birth Control To Prevent Pregnancy While Receiving Treatment And For Three Months After Treatment Is Discontinued (Will the participant practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued)
CL Item
Does (do) The Perianal Lesion(s) Have A Surface Area Of At Least 3 Square Centimeters (Does (Do) the perianal lesion(s) have a surface area of at least 3 square centimeters)
CL Item
Does The Participant Have A Biopsy-proven Perianal Hsil Within 12 Weeks Of Study Entry (Does the participant have a biopsy-proven perianal HSIL within 12 weeks of study entry)
CL Item
Date Of Biopsy (Date of biopsy)
CL Item
Does The Participant Have A Cd4 Count Of >200 (Does the participant have a CD4 count of >200)
CL Item
Does The Participant Want To Initiate Haart In The Next 12 Weeks (Does the participant want to initiate HAART in the next 12 weeks)
CL Item
Has The Participant Been On Stable Haart Therapy For At Least 12 Weeks Prior To Enrollment (Has the participant been on stable HAART therapy for at least 12 weeks prior to enrollment)
CL Item
Has The Participant Completely Healed From Treatment (Has the participant completely healed from treatment)
CL Item
Has The Participant Undergone Ablative/surgical Treatment Of Perianal Dysplasia (Has the participant undergone ablative/surgical treatment of perianal dysplasia)
CL Item
Has The Skin At The Site Of The Pretreatment Biopsy Re-epithelialized (Has the skin at the site of the pretreatment biopsy re-epithelialized)
CL Item
Is The Elevated Bilirubin Felt To Be Secondary To Indinavir Therapy (Is the elevated bilirubin felt to be secondary to Indinavir therapy)
CL Item
Is The Participant Currently Receiving Haart Therapy (Is the participant currently receiving HAART therapy)
CL Item
Is The Participant Receiving No Antiretroviral Therapy Or A Non-haart Antiretroviral Regimen (Is the participant receiving no antiretroviral therapy or a non-HAART antiretroviral regimen)
CL Item
Karnofsky Performance Status (Karnofsky performance status)
CL Item
8 g/dl); ANC (> (Were the following laboratory parameters met and performed within 28 days prior to study entry: Hemoglobin (>)
CL Item
1.5 x ULN (Is the total bilirubin <)
CL Item
3.5 mg/dl and is direct bilirubin normal (Is total bilirubin <)
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status
integer
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0206065 (UMLS CUI-1)
BiopsyDate
Item
Date of Biopsy
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C0011008 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C16112 (NCI Thesaurus Property)
C25370 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0680251 (UMLS CUI-1)
Code List
Exclusion Criteria
CL Item
Has The Subject Received Topical Treatment For Perianal Dysplasia Within 4 Weeks Of Study Entry (Has the subject received topical treatment for perianal dysplasia within 4 weeks of study entry)
CL Item
Does The Participant Have Acute, Active Opportunistic Infection (other Than Oral Thrush, Yeast Vaginitis, Or Genital Herpes) Within The Last 14 Days (Does the participant have acute, active opportunistic infection (other than oral thrush, yeast vaginitis, or genital herpes) within the last 14 days)
CL Item
Is The Participant Receiving Acute Treatment For An Infection (other Than Oral Thrush, Yeast Vaginitis Or Genital Herpes) Or Other Serious Medical Illness Within 14 Days Of Study Entry (Is the participant receiving acute treatment for an infection (other than oral thrush, yeast vaginitis or genital herpes) or other serious medical illness within 14 days of study entry)

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