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.

NCT00158860 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HS2100275
• Study Type: interventional
• Target: 384
• Locations: 5 countries
• Sites: 72

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.

Conditions

Herpes Genitalis

Keywords

VALTREX®; valaciclovir; genital herpes; HSV-2; suppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean Number of GH Recurrences Per Month Within the 6-month Study Period

  Up to Day 168

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Upto Day 168

• Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months

  Day 168

• Number of Isolates With Resistance to Acyclovir (ACV)

  Day 168

Study Arms (2)

Valaciclovir

EXPERIMENTAL

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).

Drug: Valaciclovir

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

Valaciclovir DRUG

1g once daily

Valaciclovir

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (72)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85016, United States

Location

GSK Investigational Site

Tucson, Arizona, 85710, United States

Location

GSK Investigational Site

Anaheim, California, 92805, United States

Location

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Davis, California, 95616, United States

Location

GSK Investigational Site

Fair Oaks, California, 95628, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Sacramento, California, 95816, United States

Location

GSK Investigational Site

Sacramento, California, 95825, United States

Location

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

San Diego, California, 92128, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

Santa Ana, California, 92704, United States

Location

GSK Investigational Site

Hartford, Connecticut, 06012, United States

Location

GSK Investigational Site

New Britain, Connecticut, 06052, United States

Location

GSK Investigational Site

Clearwater, Florida, 33759, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Melbourne, Florida, 32901, United States

Location

GSK Investigational Site

Palm Springs, Florida, 33461, United States

Location

GSK Investigational Site

Venice, Florida, 34285, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33407, United States

Location

GSK Investigational Site

Alpharetta, Georgia, 30005, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30310, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Springfield, Illinois, 62702, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202 - 5124, United States

Location

GSK Investigational Site

South Bend, Indiana, 46601, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70114, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Taunton, Massachusetts, 02780, United States

Location

GSK Investigational Site

Portage, Michigan, 49024, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89128, United States

Location

GSK Investigational Site

Brooklyn, New York, 11203, United States

Location

GSK Investigational Site

Endicott, New York, 13760, United States

Location

GSK Investigational Site

Stony Brook, New York, 11794-8091, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

GSK Investigational Site

East Providence, Rhode Island, 02914, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38104, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38120, United States

Location

GSK Investigational Site

Austin, Texas, 78746, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Georgetown, Texas, 78626, United States

Location

GSK Investigational Site

Houston, Texas, 77058, United States

Location

GSK Investigational Site

San Antonio, Texas, 78205, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

GSK Investigational Site

La Crosse, Wisconsin, 54601, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53209-0996, United States

Location

GSK Investigational Site

Waukesha, Wisconsin, 53186, United States

Location

GSK Investigational Site

Buenos Aires, 1221, Argentina

Location

GSK Investigational Site

Buenos Aires, C1114AAP, Argentina

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 20 551-030, Brazil

Location

GSK Investigational Site

Edmonton, Alberta, T6G 2C8, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3C 0N2, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1S 0G8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5V 2T3, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Québec, G1S 2L6, Canada

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7580206, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 8380456, Chile

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: June 21, 2004
• Primary Completion: July 26, 2006
• Study Completion: July 26, 2006
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

BR (3); US (58); CL (2); AR (2); CA (7)