ID

24555

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. 8/6/17 8/6/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 6, 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 Subject Diary NCT00079911

English

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Subject Diary NCT00079911

1 forms  
Subject Diary
Description

Subject Diary

Month number
Description

Month

Data type

integer

Alias
UMLS CUI [1]
C0439231
Subject Number
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date Diary Card Dispensed:
Description

Date Diary Card Dispensed

Data type

date

Alias
UMLS CUI [1,1]
C2987124
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C1115441
Date of Next Clinic Visit
Description

Date of Next Clinic Visit

Data type

date

Alias
UMLS CUI [1]
C2735342
Genital Herpes Recurrences
Description

Genital Herpes Recurrences

Date of Onset
Description

Date of Onset

Data type

date

Measurement units
  • day month year
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1274323
day month year
Was home viral swab obtained?
Description

viral swab

Data type

text

Alias
UMLS CUI [1]
C0563454
Oral/Other Herpes Recurrences
Description

Oral/Other Herpes Recurrences

Date of Onset
Description

date of onset

Data type

date

Measurement units
  • day month year
Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1274323
day month year
Location
Description

location

Data type

integer

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0744883
If Other, specify:
Description

If Other, specify

Data type

text

Alias
UMLS CUI [1]
C0449685
lnvestigational Product
Description

lnvestigational Product

Date
Description

date tablets missed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1709043
Number of caplets/tablets missed
Description

tablets missed

Data type

integer

Alias
UMLS CUI [1]
C1709043
Record Any Adverse Events / Illnesses
Description

Record Any Adverse Events / Illnesses

Start Date
Description

ae start date

Data type

date

Alias
UMLS CUI [1]
C2697888
End Date
Description

ae end date

Data type

date

Alias
UMLS CUI [1]
C2697886
Adverse Event/Illnesses
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Medication Record
Description

Medication Record

Start Date
Description

medication start date

Data type

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0808070
Stop Date
Description

medication end date

Data type

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Name of Medication
Description

medication

Data type

text

Alias
UMLS CUI [1]
C0013227
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Similar models

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Subject Diary NCT00079911

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Diary
Month
Item
Month number
integer
C0439231 (UMLS CUI [1])
Subject ID
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date Diary Card Dispensed
Item
Date Diary Card Dispensed:
date
C2987124 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C1115441 (UMLS CUI [1,3])
Date of Next Clinic Visit
Item
Date of Next Clinic Visit
date
C2735342 (UMLS CUI [1])
Item Group
Genital Herpes Recurrences
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1274323 (UMLS CUI [1,2])
Item
Was home viral swab obtained?
text
C0563454 (UMLS CUI [1])
viral swab
Code List
Was home viral swab obtained?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Oral/Other Herpes Recurrences
date of onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1274323 (UMLS CUI [1,2])
Item
Location
integer
C0450429 (UMLS CUI [1,1])
C0744883 (UMLS CUI [1,2])
location
Code List
Location
CL Item
Oral (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify:
text
C0449685 (UMLS CUI [1])
Item Group
lnvestigational Product
date tablets missed
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1709043 (UMLS CUI [1,2])
tablets missed
Item
Number of caplets/tablets missed
integer
C1709043 (UMLS CUI [1])
Item Group
Record Any Adverse Events / Illnesses
ae start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
ae end date
Item
End Date
date
C2697886 (UMLS CUI [1])
Adverse event
Item
Adverse Event/Illnesses
text
C0877248 (UMLS CUI [1])
Item Group
Medication Record
medication start date
Item
Start Date
date
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
medication end date
Item
Stop Date
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication
Item
Name of Medication
text
C0013227 (UMLS CUI [1])
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