ID

24378

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. 7/30/17 7/30/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 30, 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 INVESTIGATIONAL PRODUCT DISCONTINUATION NCT00079911

English

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons INVESTIGATIONAL PRODUCT DISCONTINUATION NCT00079911

1 forms  
Study administration
Description

Study administration

Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
INVESTIGATIONAL PRODUCT DISCONTINUATION
Description

INVESTIGATIONAL PRODUCT DISCONTINUATION

Was the investigational product stopped pennanently before the end of the scheduled treatment period?
Description

early discontinuation

Data type

text

Alias
UMLS CUI [1]
C4288399
If Yes, check the primary reason the investigational product was stopped:
Description

reason drug discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C4288399
UMLS CUI [1,2]
C0392360
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Similar models

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons INVESTIGATIONAL PRODUCT DISCONTINUATION 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
INVESTIGATIONAL PRODUCT DISCONTINUATION
Item
Was the investigational product stopped pennanently before the end of the scheduled treatment period?
text
C4288399 (UMLS CUI [1])
early discontinuation
Code List
Was the investigational product stopped pennanently before the end of the scheduled treatment period?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, check the primary reason the investigational product was stopped:
text
C4288399 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason drug discontinuation
Code List
If Yes, check the primary reason the investigational product was stopped:
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event (1)
CL Item
pages as appropriate) (pages as appropriate))
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Other. specify (Z)
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