ID

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

Keywords

Versions (1)
  1. 7/28/17 7/28/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 28, 2017

DOI

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License

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])
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