- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306293
VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
August 28, 2017 updated by: GlaxoSmithKline
The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed With Genital Herpes Infection
Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.
Study Overview
Study Type
Interventional
Enrollment (Actual)
70
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
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California
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Anaheim, California, United States, 92805
- GSK Investigational Site
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Carmichael, California, United States, 95608
- GSK Investigational Site
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Fair Oaks, California, United States, 95628
- GSK Investigational Site
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Sacramento, California, United States, 95816
- GSK Investigational Site
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San Diego, California, United States, 92123
- GSK Investigational Site
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Florida
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Boynton Beach, Florida, United States, 33437
- GSK Investigational Site
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Saint Petersburg, Florida, United States, 33710
- GSK Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46202
- GSK Investigational Site
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South Bend, Indiana, United States, 46601
- GSK Investigational Site
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Michigan
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Portage, Michigan, United States, 49024
- GSK Investigational Site
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New York
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New York, New York, United States, 10029
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- GSK Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74104
- GSK Investigational Site
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Oregon
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Portland, Oregon, United States, 97210
- GSK Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- GSK Investigational Site
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Tennessee
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Memphis, Tennessee, United States, 38120
- GSK Investigational Site
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Memphis, Tennessee, United States, 38104
- GSK Investigational Site
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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:
- Subject is in overall general good health.
If female, subject must be of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal or surgically sterile); or
- Childbearing potential, but must have a negative pregnancy test at randomization, and must be compliant with one of the following: Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period of 1 week after study completion or premature discontinuation from the study (to account for elimination of the drug); Have a male partner who is confirmed to be sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; Use of contraceptive(s) with a documented failure rate of less than 1% per year, including but not limited to: implants of levonorgestrel, use of injectable progestogen, oral contraceptives (either combined or progestogen only), an intrauterine device (IUD) or spermicide plus a mechanical barrier (condom/diaphragm).
- Subjects must be newly diagnosed with a first recognized episode of genital herpes as described in (a) or (b) below (See Appendix 3): a.HSV-2 seropositive at screen, with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization or b.HSV-2 seronegative at screen, AND HSV-2 culture positive or HSV-2 PCR positive with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization.
- Subject must be willing and able to provide written informed consent and comply with the protocol.
Exclusion Criteria:
- Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
- Subject received an investigational drug in the 30 days prior to the randomization visit.
- Subject is receiving systemic antiviral or immunomodulatory treatments.
- Subjects who have received systemic antiherpetic treatments (e.g., valacyclovir, acyclovir, ganciclovir, famciclovir) within 3 days of starting study drug, or immunomodulatory treatments in the 30 days before starting study drug.
- Subject has clinically significantly impaired renal function as defined by creatinine clearance less than 50ml/min (calculated using the Cockcroft-Gault formula).
- Subjects with a history or evidence of decompensated liver disease, or clinically significantly impaired hepatic function defined as an ALT (alanine transaminase) level >3 times the normal upper limit.
- Subject is known to be hypersensitive to valacyclovir, acyclovir, ganciclovir or famciclovir.
- Subject has malabsorption or vomiting syndrome or other gastrointestinal dysfunction that may impair drug pharmacokinetics.
- Female subject who is contemplating pregnancy within the duration of the study drug dosing period.
- Female subject who is pregnant and/or nursing.
- Subject with current alcohol or drug abuse.
- Subjects who have received suppressive (daily) therapy for genital herpes prior to randomization. Suppressive therapy is defined as daily antiherpetic therapy of at least 4 weeks duration.
- Subjects with a history of ocular HSV (herpes simplex virus) infection.
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: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2)
Time Frame: Up to 60 days in each treatment period (Up to 148 days)
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Each participant's study day were classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR.
If either the daily genital swab or a lesion swab are positive, the day was classified as 'shedding'.
Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits.
Percent of days with HSV-2 shedding was defined for each participant as the percent of days with PCR data for which HSV-2 shedding was detected by a positive PCR result, i.e., the number of days with HSV-2 PCR shedding divided by total number of days with PCR data, multiplied by 100.
Sum of the percent clinical and nonclinical shedding days was reported as total shedding.
Mean percent of days with HSV-2 shedding was reported for each treatment group.
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Up to 60 days in each treatment period (Up to 148 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
Time Frame: Up to 60 days in each treatment period (Up to 148 days)
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The percent of days with subclinical HSV-2 shedding was defined as the percent of all days with PCR data for which subclinical HSV-2 shedding was detected (shedding in the absence of a genital lesion).
Mean percent of days with subclinical HSV-2 shedding was reported for each treatment group.
Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR.
If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'.
Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits.
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Up to 60 days in each treatment period (Up to 148 days)
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Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
Time Frame: Up to 60 days in each treatment period (Up to 148 days)
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The percent of days with clinical HSV-2 shedding was defined as the percent of all days with PCR data for which clinical HSV-2 shedding was detected (shedding in the presence of a genital lesion).
Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR.
If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'.
Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits.
Mean percent of days with clinical HSV-2 shedding was reported for each treatment group.
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Up to 60 days in each treatment period (Up to 148 days)
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Percentage of Participants With no Shedding
Time Frame: Up to 60 days in each treatment period (Up to 148 days)
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The proportion of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data in the Treatment Period.
Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR.
If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'.
Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits.
Mean percent of days with no shedding was reported for each treatment group.
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Up to 60 days in each treatment period (Up to 148 days)
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Percentage of Participants With at Least One Genital Herpes Recurrence
Time Frame: Up to 60 days in each treatment period (Up to 148 days)
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The proportion of participants with at least one genital herpes recurrence was defined as the number of participants with at least one investigator-confirmed genital herpes recurrence divided by the total number of participants with at least one clinic visit in the treatment period.
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Up to 60 days in each treatment period (Up to 148 days)
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Median Time to First Genital Herpes Recurrence (Days)
Time Frame: Up to Day 68
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Time to first genital herpes recurrence was evaluated using Kaplan-Meier estimates of investigator-confirmed genital herpes recurrences censoring the data from participants who prematurely discontinue the study at the time of discontinuation.
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Up to Day 68
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Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Time Frame: Up to 148 days
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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.
SAE include adverse events that result in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
No SAEs were reported in this study.
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Up to 148 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
February 20, 2006
Primary Completion (Actual)
November 27, 2006
Study Completion (Actual)
November 27, 2006
Study Registration Dates
First Submitted
March 21, 2006
First Submitted That Met QC Criteria
March 21, 2006
First Posted (Estimate)
March 23, 2006
Study Record Updates
Last Update Posted (Actual)
March 23, 2018
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLX105832
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
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Statistical Analysis Plan
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: VLX105832Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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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