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.

Herpes Genitalis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158860
• Other study ID #: HS2100275
• Status: Completed
• Phase: Phase 4
• Start date: June 21, 2004
• Est. completion date: July 26, 2006

Study information

• Verified date: December 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: July 26, 2006
• Est. primary completion date: July 26, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Genitalis

Intervention

Drug:
• Valaciclovir
1g once daily
• Placebo
placebo

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Brazil	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
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Québec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
United States	GSK Investigational Site	Alpharetta	Georgia
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Davis	California
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	Endicott	New York
United States	GSK Investigational Site	Fair Oaks	California
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Georgetown	Texas
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	New Britain	Connecticut
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Palm Springs	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Portage	Michigan
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
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	South Bend	Indiana
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Taunton	Massachusetts
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Venice	Florida
United States	GSK Investigational Site	Waukesha	Wisconsin
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Time to First GH Recurrence	Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.	Day 168
Secondary	Mean Number of GH Recurrences Per Month Within the 6-month Study Period	Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant.	Up to Day 168
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant.	Upto Day 168
Secondary	Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months	Diary cards were issued to the participants during randomization visit for recording HSV outbreak within 6-momths. HSV outbreak was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported.	Day 168
Secondary	Number of Isolates With Resistance to Acyclovir (ACV)	Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV.	Day 168

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