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VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116844
First received: June 30, 2005
Last updated: March 17, 2011
Last verified: March 2011

June 30, 2005
March 17, 2011
March 2005
January 2006   (final data collection date for primary outcome measure)
To determine the effect of valaciclovir 1g once daily for 60 days on HSV-2 viral shedding. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Effect of valacyclovir 1g once daily for 60 days on HSV-2 viral shedding
Complete list of historical versions of study NCT00116844 on ClinicalTrials.gov Archive Site
To determine the safety of valaciclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Safety of valacyclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection
Not Provided
Not Provided
 
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Way Crossover Study to Investigate the Effect of VALTREX 1g Once Daily for 60 Days on Viral Shedding in HSV-2 Seropositive Subjects With No Previous History of Symptomatic Genital Herpes Infection.

Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Genital Herpes
  • Infections, Herpesviridae
Drug: Valaciclovir
Valtrex 1g QD
Other Name: Valaciclovir
  • Placebo Comparator: Placebo
    Val vs Placebo
    Intervention: Drug: Valaciclovir
  • Active Comparator: 1g QD
    Valtrex
    Intervention: Drug: Valaciclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
January 2006
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • In overall general good health.
  • HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion criteria:

  • have active lesions consistent with genital herpes.
  • previous history of symptomatic genital herpes.
  • history of recurrent, undiagnosed symptoms consistent with genital herpes.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116844
VLX103596
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP