Clinical trial NCT00116844: VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Official title: Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections, Herpesviridae
Keywords: viral shedding
Recurrent
herpes
genital herpes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
timeFrame: Up to Day 60 of each treatment period (up to 160 days)
Secondary outcomes:
measure: Mean Percent Days of Total HSV-2 Shedding
timeFrame: Up to Day 60 of each treatment period (up to 160 days)
measure: Number of Participants With no Shedding
timeFrame: Up to Day 60 of each treatment period (up to 160 days)
measure: Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
timeFrame: Up to Day 60 of each treatment period (up to 160 days)
measure: Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
timeFrame: Up to Day 60 of each treatment period (up to 160 days)
measure: Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
timeFrame: Up to Day 60 of each treatment period (up to 160 days)
Other outcomes:
Locations:
city: Carmichael
country: United States
facility: GSK Investigational Site
state: California
city: Davis
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Fort Wayne
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Stony Brook
country: United States
facility: GSK Investigational Site
state: New York
city: The Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: