CompletedNCT00306293Updated Mar 23, 2018Results posted

VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2

A Phase 4 interventional study of valacyclovir in Herpes Labialis, sponsored by GlaxoSmithKline. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Herpes Labialis

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Keywords

Recurrent Genital Herpes

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 70 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject is in overall general good health.
If female, subject must be of:
1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal or surgically sterile); or
2. 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

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 design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 70 participants (actual)

Interventions

Drugvalacyclovir
valacyclovir

What researchers measure

Primary outcomes

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.
Time frame: Up to 60 days in each treatment period (Up to 148 days)

Secondary outcomes

Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
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.
Time frame: Up to 60 days in each treatment period (Up to 148 days)
Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
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.
Time frame: Up to 60 days in each treatment period (Up to 148 days)
Percentage of Participants With no Shedding
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.
Time frame: Up to 60 days in each treatment period (Up to 148 days)
Percentage of Participants With at Least One Genital Herpes Recurrence
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.
Time frame: Up to 60 days in each treatment period (Up to 148 days)
Median Time to First Genital Herpes Recurrence (Days)
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.
Time frame: Up to Day 68
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
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.
Time frame: Up to 148 days

Results

Posted Mar 23, 2018

Participant flow

Seventy participants were enrolled at 14 centers in the United States. The study was conducted between 20 February 2006 and 28 November 2006.

Period 1 (Day 1 to Day 60)

Participant flow — Period 1 (Day 1 to Day 60)
Milestone	VALTREX 1 g First Then Placebo	Placebo First Then VALTREX 1 g
Started	35	35
Completed	27	27
Not completed	8	8
Withdrew: Adverse event	1	0
Withdrew: Lost to follow-up	3	4
Withdrew: Withdrawal by subject	2	2
Withdrew: Positive pregnancy test	2	2

Washout (Day 61 to Day 66)

Participant flow — Washout (Day 61 to Day 66)
Milestone	VALTREX 1 g First Then Placebo	Placebo First Then VALTREX 1 g
Started	27	27
Completed	27	27
Not completed	0	0

Period 2 (Day 67 to Day 126 )

Participant flow — Period 2 (Day 67 to Day 126 )
Milestone	VALTREX 1 g First Then Placebo	Placebo First Then VALTREX 1 g
Started	27	27
Completed	24	26
Not completed	3	1
Withdrew: Adverse event	1	0
Withdrew: Lost to follow-up	1	0
Withdrew: Participant determined hsv-2 negative	0	1
Withdrew: Pregnancy	1	0

Outcome measures

PrimaryMean 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.

Time frame:: Up to 60 days in each treatment period (Up to 148 days)
Reported as:: Mean · Percent of days

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)
Percent of days	VALTREX 1 g, OD	Placebo
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)	2.9 ± 5.6	13.5 ± 16.9

SecondaryMean Percent Days Subclinical Shedding (no Genital Lesions Present)

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.

Time frame:: Up to 60 days in each treatment period (Up to 148 days)
Reported as:: Mean · Percentage of days

Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
Percentage of days	VALTREX 1 g, OD	Placebo
Mean Percent Days Subclinical Shedding (no Genital Lesions Present)	2.4 ± 4.8	11 ± 15.1

Statistical analysis

VALTREX 1 g, OD vs Placebo · Wilcoxon Rank Sum Test · p = <0.001 · Percent change from placebo: -78Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo

SecondaryMean Percent Days Clinical Shedding (Presence of Genital Lesions)

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.

Time frame:: Up to 60 days in each treatment period (Up to 148 days)
Reported as:: Mean · Percentage of Days

Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
Percentage of Days	VALTREX 1 g, OD	Placebo
Mean Percent Days Clinical Shedding (Presence of Genital Lesions)	0.6 ± 1.7	2.4 ± 4.4

Statistical analysis

VALTREX 1 g, OD vs Placebo · Wilcoxon Rank Sum · p = 0.014 · Percent change from baseline: -77Percent change in 'percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo

SecondaryPercentage of Participants With no Shedding

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.

Time frame:: Up to 60 days in each treatment period (Up to 148 days)
Reported as:: Number · Percentage of participants

Percentage of Participants With no Shedding
Percentage of participants	VALTREX 1 g, OD	Placebo
Percentage of Participants With no Shedding	60	29

SecondaryPercentage of Participants With at Least One Genital Herpes Recurrence

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.

Time frame:: Up to 60 days in each treatment period (Up to 148 days)
Reported as:: Number · Percetage of participants

Percentage of Participants With at Least One Genital Herpes Recurrence
Percetage of participants	VALTREX 1 g, OD	Placebo
Percentage of Participants With at Least One Genital Herpes Recurrence	21	48

SecondaryMedian Time to First Genital Herpes Recurrence (Days)

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.

Time frame:: Up to Day 68
Reported as:: Median · Days

Median Time to First Genital Herpes Recurrence (Days)
Days	VALTREX 1 g First Then Placebo	Placebo First Then VALTREX 1 g
Median Time to First Genital Herpes Recurrence (Days)	NA (11 to NA)	61 (4 to 61)

SecondaryNumber of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)

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.

Time frame:: Up to 148 days
Reported as:: Count of participants · Participants

Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Participants	VALTREX 1 g, OD	Placebo
Any AE	19	26
Any SAE	0	0

Adverse events

Collected over AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
VALTREX 1 g, OD	0/62 (0%)	0/62 (0%)	19/62 (30.6%)
Placebo	0/62 (0%)	0/62 (0%)	26/62 (41.9%)

Most frequent other events

Showing 10 of 54

Most frequent other events
Event	VALTREX 1 g, OD	Placebo
Fungal infectionInfections and infestations	3/62	6/62
Upper respiratory tract infectionInfections and infestations	3/62	1/62
SinusitisInfections and infestations	2/62	1/62
Vaginitis bacterialInfections and infestations	2/62	1/62
BronchitisInfections and infestations	2/62	0/62
Ear infectionInfections and infestations	2/62	0/62
Vulvovaginal mycotic infectionInfections and infestations	2/62	0/62
Vulvovaginitis trichomonalInfections and infestations	0/62	2/62
ContusionInjury, poisoning and procedural complications	0/62	2/62
DiarrhoeaGastrointestinal disorders	1/62	2/62

Baseline characteristics

Age, Continuous
Age, Continuous(Year)	Overall Study
Mean	30.9 ± 9.64

Sex: Female, Male
Sex: Female, Male(Participants)	Overall Study
Female	49
Male	21

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Overall Study
African American/African Heritage	28
American Indian or Alaska Native	2
Asian - East Asian Heritage	2
White - Arabic/North African Heritage	1
White - White/Caucasian/European Heritage	36
Mixed Race	1

Study locations

18 sites

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
Saint 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

References and documents

Individual participant data

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00306293
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Mar 23, 2006
Start date: Feb 20, 2006
Primary completion: Nov 27, 2006
Completion: Nov 27, 2006
Results posted: Mar 23, 2018
Last update: Mar 23, 2018

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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