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.
NCT ID: NCT00158860
Last Updated: 2019-02-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
384 participants
INTERVENTIONAL
2004-06-21
2006-07-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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.
NCT00116844
VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
NCT00306293
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
NCT00005663
Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT01346475
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
NCT02152800
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Valaciclovir
Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks).
Valaciclovir
1g once daily
Placebo
Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).
Placebo
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Valaciclovir
1g once daily
Placebo
placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Davis, California, United States
GSK Investigational Site
Fair Oaks, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Santa Ana, California, United States
GSK Investigational Site
Hartford, Connecticut, United States
GSK Investigational Site
New Britain, Connecticut, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Melbourne, Florida, United States
GSK Investigational Site
Palm Springs, Florida, United States
GSK Investigational Site
Venice, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Alpharetta, Georgia, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Springfield, Illinois, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
South Bend, Indiana, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Taunton, Massachusetts, United States
GSK Investigational Site
Portage, Michigan, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Brooklyn, New York, United States
GSK Investigational Site
Endicott, New York, United States
GSK Investigational Site
Stony Brook, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
East Providence, Rhode Island, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Georgetown, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Spokane, Washington, United States
GSK Investigational Site
La Crosse, Wisconsin, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Waukesha, Wisconsin, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Rio de Janeiro, , Brazil
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Sainte-Foy, Quebec, Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
Countries
Review the countries where the study has at least one active or historical site.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HS2100275
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.