ID

24264

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-07-28 2017-07-28 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

28 juli 2017

DOI

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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

Engelsk

GSK Study Randomisation Visit HISTORY OF HERPES INFECTIONS NCT00079911

1 Formulär  
Study administration
Beskrivning

Study administration

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Måttenheter
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1320303
DD/MMM/YY
HISTORY OF HERPES INFECTIONS
Beskrivning

HISTORY OF HERPES INFECTIONS

Date of initial episode of genital herpes
Beskrivning

herpes onset

Datatyp

date

Måttenheter
  • 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?
Beskrivning

herpes treatment

Datatyp

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?
Beskrivning

genital herpes recurrences

Datatyp

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
Beskrivning

If Yes, complete the following:

Datatyp

date

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

suppressive therapy end date

Datatyp

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?
Beskrivning

herpes recurrences prior to therapy

Datatyp

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?
Beskrivning

oral herpes

Datatyp

boolean

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

non-genital/non-oral herpes

Datatyp

boolean

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

specify non-genital/non-oral herpes

Datatyp

text

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

GENITAL EXAMINATION

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

genital examination

Datatyp

text

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

If Yes, complete the following:

Datatyp

text

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

other abnormal findings

Datatyp

text

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

specify abnormal findings

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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