Clinical trial NCT00158860: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Genitalis
Keywords: VALTREX®
valaciclovir
genital herpes
HSV-2
suppression
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* In overall general good health.
* Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
* Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.

Exclusion criteria:

* Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
* Received an investigational drug in the 30 days prior to the study.
* Receiving systemic antiviral or immunomodulatory treatments.
* Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
* Clinically significant impaired renal function as defined by a creatinine clearance \<30 ml/min, calculated using the Cockcroft-Gault formula.
* Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level \> 5 times the normal upper limit.
* Subjects with active liver disease.
* Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
* Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
* Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
* Women contemplating pregnancy within the duration of the study drug dosing period.
* Women who are pregnant and/or nursing mothers
* Current history of alcohol or drug abuse.
* Received suppressive (daily) therapy for genital herpes prior to enrollment.

Primary outcomes:
measure: Percentage of Participants With Time to First GH Recurrence
timeFrame: Day 168
Secondary outcomes:
measure: Mean Number of GH Recurrences Per Month Within the 6-month Study Period
timeFrame: Up to Day 168
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Upto Day 168
measure: Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
timeFrame: Day 168
measure: Number of Isolates With Resistance to Acyclovir (ACV)
timeFrame: Day 168
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Davis
country: United States
facility: GSK Investigational Site
state: California
city: Fair Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Palm Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Venice
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Springfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Taunton
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Portage
country: United States
facility: GSK Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Endicott
country: United States
facility: GSK Investigational Site
state: New York
city: Stony Brook
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Waukesha
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: