VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.

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ClinicalTrials.gov Identifier: NCT00116844

Recruitment Status : Completed

First Posted : July 1, 2005

Results First Posted : February 12, 2018

Last Update Posted : February 12, 2018

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

Condition or disease	Intervention/treatment	Phase
Infections, Herpesviridae	Drug: Valaciclovir Drug: Placebo	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
Actual Study Start Date :	March 29, 2005
Actual Primary Completion Date :	January 10, 2006
Actual Study Completion Date :	January 10, 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Valacyclovir Valacyclovir hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sequence 1: VALTREX 1 g once daily, Placebo VALTREX 1 g once daily, Placebo	Drug: Valaciclovir Valtrex 1g once daily Drug: Placebo placebo
Experimental: Sequence 2: Placebo, VALTREX 1 g once daily Placebo, VALTREX 1 g once daily	Drug: Valaciclovir Valtrex 1g once daily Drug: Placebo placebo

Outcome Measures

Primary Outcome Measures :

Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2 [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.

Secondary Outcome Measures :

Mean Percent Days of Total HSV-2 Shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Number of Participants With no Shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
The number 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. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

In overall general good health.
HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion criteria:

have active lesions consistent with genital herpes.
previous history of symptomatic genital herpes.
history of recurrent, undiagnosed symptoms consistent with genital herpes.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116844

Locations


United States, California
GSK Investigational Site
Carmichael, California, United States, 95608
GSK Investigational Site
Davis, California, United States, 95616
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
Sacramento, California, United States, 92585
United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, New York
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
New York, New York, United States, 10029
GSK Investigational Site
Stony Brook, New York, United States, 11794
GSK Investigational Site
The Bronx, New York, United States, 10461
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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