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.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00116844 |
Recruitment Status
:
Completed
First Posted
: July 1, 2005
Results First Posted
: February 12, 2018
Last Update Posted
: February 12, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infections, Herpesviridae | Drug: Valaciclovir Drug: Placebo | Phase 4 |
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 |
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
|
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00116844 History of Changes |
Obsolete Identifiers: | NCT00268190 |
Other Study ID Numbers: |
VLX103596 |
First Posted: | July 1, 2005 Key Record Dates |
Results First Posted: | February 12, 2018 |
Last Update Posted: | February 12, 2018 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
URL: | http:// |
Keywords provided by GlaxoSmithKline:
viral shedding Recurrent herpes genital herpes |
Additional relevant MeSH terms:
Herpesviridae Infections DNA Virus Infections Virus Diseases Valacyclovir |
Acyclovir Antiviral Agents Anti-Infective Agents |