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.

• 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: GlaxoSmithKline
• 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

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 :

1. 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 :

1. 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.
2. 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).
3. 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).
4. 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).
5. 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Dataset Specification 

Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: VLX103596
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
• 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.

Keywords provided by GlaxoSmithKline:

viral shedding; Recurrent; herpes; genital herpes

Additional relevant MeSH terms:

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Valacyclovir; Antiviral Agents; Anti-Infective Agents