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24264

Description

NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

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  1. 7/28/17 7/28/17 -
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GlaxoSmithKline

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July 28, 2017

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Creative Commons BY-NC 3.0
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    GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Randomisation Visit HISTORY OF HERPES INFECTIONS NCT00079911

    English

    GSK Study Randomisation Visit HISTORY OF HERPES INFECTIONS NCT00079911

    1 forms  
    Study administration
    Description

    Study administration

    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C1320303
    DD/MMM/YY
    HISTORY OF HERPES INFECTIONS
    Description

    HISTORY OF HERPES INFECTIONS

    Date of initial episode of genital herpes
    Description

    herpes onset

    Data type

    date

    Measurement units
    • MMM-YYYY
    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0019342
    MMM-YYYY
    Has the subject received chronic suppressive anti-herpetic therapy within the previous 12 months?
    Description

    herpes treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0319232
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C3843288
    If No, what was the approximate number of genital Herpes recurrences in the previous 12 months?
    Description

    genital herpes recurrences

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0019342
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C0449788
    Date of most recent suppressive therapy period: From
    Description

    If Yes, complete the following:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0319232
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C0808070
    To
    Description

    suppressive therapy end date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0319232
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C0806020
    What was the approximate number of genital Herpes recurrences in the 12 months Prior to initiating suppressive therapy?
    Description

    herpes recurrences prior to therapy

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0019342
    UMLS CUI [1,2]
    C0034897
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C0319232
    UMLS CUI [1,5]
    C0013216
    Has the subject ever had herpes infections in the oral area?
    Description

    oral herpes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0341012
    Has the subject ever had herpes infections in any other non-genital/non-oral areas?
    Description

    non-genital/non-oral herpes

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019348
    UMLS CUI [1,2]
    C0205394
    If Yes, specify:
    Description

    specify non-genital/non-oral herpes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0019348
    UMLS CUI [1,2]
    C0205394
    GENITAL EXAMINATION
    Description

    GENITAL EXAMINATION

    Alias
    UMLS CUI-1
    C0849001
    UMLS CUI-2
    C0849002
    Was a genital examination performed on the subject?
    Description

    genital examination

    Data type

    text

    Alias
    UMLS CUI [1]
    C0849001
    UMLS CUI [2]
    C0849002
    Were any herpes lesions present?
    Description

    If Yes, complete the following:

    Data type

    text

    Alias
    UMLS CUI [1]
    C0744883
    Were any other abnormal findings present?
    Description

    other abnormal findings

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826636
    UMLS CUI [2,1]
    C0849001
    UMLS CUI [2,2]
    C0849002
    If Yes, specify:
    Description

    specify abnormal findings

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826636
    UMLS CUI [2,1]
    C0849001
    UMLS CUI [2,2]
    C0849002
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    Similar models

    GSK Study Randomisation Visit HISTORY OF HERPES INFECTIONS NCT00079911

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Study administration
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    HISTORY OF HERPES INFECTIONS
    herpes onset
    Item
    Date of initial episode of genital herpes
    date
    C0574845 (UMLS CUI [1,1])
    C0019342 (UMLS CUI [1,2])
    herpes treatment
    Item
    Has the subject received chronic suppressive anti-herpetic therapy within the previous 12 months?
    boolean
    C0319232 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C3843288 (UMLS CUI [1,3])
    genital herpes recurrences
    Item
    If No, what was the approximate number of genital Herpes recurrences in the previous 12 months?
    integer
    C0019342 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    suppressive therapy start date
    Item
    Date of most recent suppressive therapy period: From
    date
    C0319232 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    suppressive therapy end date
    Item
    To
    date
    C0319232 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    herpes recurrences prior to therapy
    Item
    What was the approximate number of genital Herpes recurrences in the 12 months Prior to initiating suppressive therapy?
    integer
    C0019342 (UMLS CUI [1,1])
    C0034897 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C0319232 (UMLS CUI [1,4])
    C0013216 (UMLS CUI [1,5])
    oral herpes
    Item
    Has the subject ever had herpes infections in the oral area?
    boolean
    C0341012 (UMLS CUI [1])
    non-genital/non-oral herpes
    Item
    Has the subject ever had herpes infections in any other non-genital/non-oral areas?
    boolean
    C0019348 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    specify non-genital/non-oral herpes
    Item
    If Yes, specify:
    text
    C0019348 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    GENITAL EXAMINATION
    C0849001 (UMLS CUI-1)
    C0849002 (UMLS CUI-2)
    Item
    Was a genital examination performed on the subject?
    text
    C0849001 (UMLS CUI [1])
    C0849002 (UMLS CUI [2])
    entry criteria
    Code List
    Was a genital examination performed on the subject?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any herpes lesions present?
    text
    C0744883 (UMLS CUI [1])
    entry criteria
    Code List
    Were any herpes lesions present?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any other abnormal findings present?
    text
    C2826636 (UMLS CUI [1])
    C0849001 (UMLS CUI [2,1])
    C0849002 (UMLS CUI [2,2])
    entry criteria
    Code List
    Were any other abnormal findings present?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    specify abnormal findings
    Item
    If Yes, specify:
    text
    C2826636 (UMLS CUI [1])
    C0849001 (UMLS CUI [2,1])
    C0849002 (UMLS CUI [2,2])
    Back to the top of the page 

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