VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed With Genital Herpes Infection
1 other identifier
interventional
70
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2006
Shorter than P25 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2006
CompletedFirst Posted
Study publicly available on registry
March 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2006
CompletedResults Posted
Study results publicly available
March 23, 2018
CompletedMarch 23, 2018
August 1, 2017
9 months
March 21, 2006
April 14, 2017
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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.
Up to 60 days in each treatment period (Up to 148 days)
Secondary Outcomes (6)
Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
Up to 60 days in each treatment period (Up to 148 days)
Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
Up to 60 days in each treatment period (Up to 148 days)
Percentage of Participants With no Shedding
Up to 60 days in each treatment period (Up to 148 days)
Percentage of Participants With at Least One Genital Herpes Recurrence
Up to 60 days in each treatment period (Up to 148 days)
Median Time to First Genital Herpes Recurrence (Days)
Up to Day 68
- +1 more secondary outcomes
Interventions
valacyclovir
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (18)
GSK Investigational Site
Anaheim, California, 92805, United States
GSK Investigational Site
Carmichael, California, 95608, United States
GSK Investigational Site
Fair Oaks, California, 95628, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Boynton Beach, Florida, 33437, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Portage, Michigan, 49024, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Memphis, Tennessee, 38104, United States
GSK Investigational Site
Memphis, Tennessee, 38120, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2006
First Posted
March 23, 2006
Study Start
February 20, 2006
Primary Completion
November 27, 2006
Study Completion
November 27, 2006
Last Updated
March 23, 2018
Results First Posted
March 23, 2018
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.