ID

24554

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 (2)
  1. 7/30/17 7/30/17 -
  2. 8/6/17 8/6/17 -
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 INVESTIGATIONAL PRODUCT COMPLIANCE NCT00079911

English

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

1 forms  
Study administration
Description

Study administration

Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
INVESTIGATIONAL PRODUCT COMPLIANCE
Description

INVESTIGATIONAL PRODUCT COMPLIANCE

Investigational Product
Description

Check carefully for any overlapping start/stop date. Ensure any deviations from investigational product are recorded correctly as outlined in the study protocol. Record a new start and stop date if greater than or equal to one day of dosing is missed.

Data type

integer

Alias
UMLS CUI [1]
C0304229
Date Investigational Product Dispensed
Description

dispension date

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1115441
DD/MMM/YY
Date Investigational Product Returned
Description

date product returned

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2826249
DD/MMM/YY
Number of Tablets/Caplets Dispensed
Description

dispensed amount

Data type

integer

Alias
UMLS CUI [1]
C0805077
Number of Tablets/Caplets Returned
Description

returned amount

Data type

integer

Alias
UMLS CUI [1]
C2699071
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Similar models

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons INVESTIGATIONAL PRODUCT COMPLIANCE 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 COMPLIANCE
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Investigational Product
Code List
Investigational Product
CL Item
Double-Blind therapy (23)
CL Item
Open-label treatment (24)
dispension date
Item
Date Investigational Product Dispensed
date
C0013230 (UMLS CUI [1,1])
C1115441 (UMLS CUI [1,2])
date product returned
Item
Date Investigational Product Returned
date
C0013230 (UMLS CUI [1,1])
C2826249 (UMLS CUI [1,2])
dispensed amount
Item
Number of Tablets/Caplets Dispensed
integer
C0805077 (UMLS CUI [1])
returned amount
Item
Number of Tablets/Caplets Returned
integer
C2699071 (UMLS CUI [1])
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