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.

September 28, 2018 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1114AAP
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1221
        • GSK Investigational Site
  • Brazil
      • Rio de Janeiro, Brazil, 20 551-030
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • GSK Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
        • GSK Investigational Site
  • Canada
      • Québec, Canada, G1S 2L6
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1S 0G8
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5V 2T3
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7580206
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 8380456
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85710
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92805
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90211
        • GSK Investigational Site
      • Davis, California, United States, 95616
        • GSK Investigational Site
      • Fair Oaks, California, United States, 95628
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Sacramento, California, United States, 95825
        • GSK Investigational Site
      • Sacramento, California, United States, 95816
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • San Diego, California, United States, 92128
        • GSK Investigational Site
      • San Francisco, California, United States, 94102
        • GSK Investigational Site
      • Santa Ana, California, United States, 92704
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06012
        • GSK Investigational Site
      • New Britain, Connecticut, United States, 06052
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • GSK Investigational Site
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Palm Springs, Florida, United States, 33461
        • GSK Investigational Site
      • Venice, Florida, United States, 34285
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • GSK Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30310
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Springfield, Illinois, United States, 62702
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202 - 5124
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46601
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • GSK Investigational Site
      • Taunton, Massachusetts, United States, 02780
        • GSK Investigational Site
    • Michigan
      • Portage, Michigan, United States, 49024
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11203
        • GSK Investigational Site
      • Endicott, New York, United States, 13760
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794-8091
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • GSK Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38104
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78746
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Georgetown, Texas, United States, 78626
        • GSK Investigational Site
      • Houston, Texas, United States, 77058
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78205
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • GSK Investigational Site
      • Milwaukee, Wisconsin, United States, 53209-0996
        • GSK Investigational Site
      • Waukesha, Wisconsin, United States, 53186
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Valaciclovir
1g once daily
Placebo Comparator: 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).
Drug: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Time to First GH Recurrence
Time Frame: Day 168
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of GH Recurrences Per Month Within the 6-month Study Period
Time Frame: Up to Day 168
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
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Upto Day 168
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
Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
Time Frame: Day 168
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
Number of Isolates With Resistance to Acyclovir (ACV)
Time Frame: Day 168
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2004

Primary Completion (Actual)

July 26, 2006

Study Completion (Actual)

July 26, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS2100275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: HS2100275
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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