Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158860
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2005-09-08
Brief Title:
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients VALTREX Tablet is a Trademark of the GlaxoSmithKline Group of Companies
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An International Randomized Double-Blind Placebo-Controlled Multicenter 6-Month Study of the Efficacy and Safety of Valtrex 1g QD vs Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Patients
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Genital herpes GH is a commonly occurring sexually transmitted disease caused by herpes simplex virus HSV There are two types of HSV type 1 HSV-1 and type 2 HSV-2 both can cause GH although the latter is much more likely to produce frequent recurrences of GH lesions Evidence suggests that there are advantages to using suppressive vs episodic treatment which include increased intervals between the pain and discomfort of genital herpes recurrences Therefore this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None