ID

24414

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 STUDY CONCLUSION NCT00079911

English

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

1 forms  
Study administration
Description

Study administration

Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
STUDY CONCLUSION
Description

STUDY CONCLUSION

Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2983670
DD/MMM/YY
Was the subject withdrawn from the study?
Description

patient withdrawal

Data type

text

Alias
UMLS CUI [1]
C0422727
What was the primary reason for withdrawal?
Description

Withdrawal reason

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
Other, specify
Description

withdrawal reason

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
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Similar models

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons STUDY CONCLUSION 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
STUDY CONCLUSION
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
patient withdrawal
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
What was the primary reason for withdrawal?
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Withdrawal reason
Code List
What was the primary reason for withdrawal?
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
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)
withdrawal reason
Item
Other, specify
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
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