ID

24504

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. 2017-08-03 2017-08-03 -
Copyright Holder

GlaxoSmithKline

Uploaded on

3 augusti 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 GENITAL HERPES RECURRENCES NCT00079911

English

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons GENITAL HERPES RECURRENCES NCT00079911

1 forms  
Study administration
Description

Study administration

Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
GENITAL HERPES RECURRENCES
Description

GENITAL HERPES RECURRENCES

Date of Onset of Recurrence
Description

Date of Onset of Recurrence

Data type

date

Alias
UMLS CUI [1]
C0807712
Was the herpes recurrence confinned by examination?
Description

recurrence confirmed

Data type

text

Alias
UMLS CUI [1,1]
C1274323
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0031809
If Examined, Date of Exam
Description

Date of Exam

Data type

date

Alias
UMLS CUI [1]
C2826643
Date Home Culture Collected
Description

Date Home Culture Collected

Data type

date

Alias
UMLS CUI [1,1]
C1294251
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C1317250
Date Clinic Culture Collected
Description

Date Clinic Culture Collected

Data type

date

Alias
UMLS CUI [1,1]
C1294251
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C1317250
Was a 5 day course of Open-Label Valaciclovir dispensed?
Description

If Yes, record Open-Label Valaciclovir on lnvestigational Product page.

Data type

text

Alias
UMLS CUI [1]
C0249458
Was there a Day 5 visit?
Description

day 5 visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C3842674
If there was a Day 5 Visit, record date
Description

day 5 visit date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C3842674
Was an additional 5 day course of Open-Label Valaciclovir dispensed?
Description

If Yes, record Open-Label Valaciclovir on lnvestigational Product page.

Data type

text

Alias
UMLS CUI [1,1]
C0249458
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C3842674
Was there a Day 10 visit?
Description

day 10 visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0205456
If there was a Day 10 Visit, record date
Description

day 10 visit date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0205456
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Similar models

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons GENITAL HERPES RECURRENCES 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])
Item Group
GENITAL HERPES RECURRENCES
Date of Onset of Recurrence
Item
Date of Onset of Recurrence
date
C0807712 (UMLS CUI [1])
Item
Was the herpes recurrence confinned by examination?
text
C1274323 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
valaciclovir
Code List
Was the herpes recurrence confinned by examination?
CL Item
Yes (Y)
CL Item
No (N)
Date of Exam
Item
If Examined, Date of Exam
date
C2826643 (UMLS CUI [1])
Date Home Culture Collected
Item
Date Home Culture Collected
date
C1294251 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,3])
Date Clinic Culture Collected
Item
Date Clinic Culture Collected
date
C1294251 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,3])
Item
Was a 5 day course of Open-Label Valaciclovir dispensed?
text
C0249458 (UMLS CUI [1])
valaciclovir
Code List
Was a 5 day course of Open-Label Valaciclovir dispensed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was there a Day 5 visit?
text
C0545082 (UMLS CUI [1,1])
C3842674 (UMLS CUI [1,2])
valaciclovir
Code List
Was there a Day 5 visit?
CL Item
Yes (Y)
CL Item
No (N)
day 5 visit date
Item
If there was a Day 5 Visit, record date
date
C1320303 (UMLS CUI [1,1])
C3842674 (UMLS CUI [1,2])
Item
Was an additional 5 day course of Open-Label Valaciclovir dispensed?
text
C0249458 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C3842674 (UMLS CUI [1,3])
valaciclovir
Code List
Was an additional 5 day course of Open-Label Valaciclovir dispensed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was there a Day 10 visit?
text
C0545082 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0205456 (UMLS CUI [1,3])
valaciclovir
Code List
Was there a Day 10 visit?
CL Item
Yes (Y)
CL Item
No (N)
day 10 visit date
Item
If there was a Day 10 Visit, record date
date
C1320303 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0205456 (UMLS CUI [1,3])
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