Infections, Herpesviridae Clinical Trial
Official title:
Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
| Verified date | August 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 73 |
| Est. completion date | January 10, 2006 |
| Est. primary completion date | January 10, 2006 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Carmichael | California |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Davis | California |
| United States | GSK Investigational Site | Fort Wayne | Indiana |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Riverside | California |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Stony Brook | New York |
| United States | GSK Investigational Site | The Bronx | New York |
| United States | GSK Investigational Site | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2 | 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. | Up to Day 60 of each treatment period (up to 160 days) | |
| Secondary | Mean Percent Days of Total HSV-2 Shedding | 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. | Up to Day 60 of each treatment period (up to 160 days) | |
| Secondary | Number of Participants With no Shedding | 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). | Up to Day 60 of each treatment period (up to 160 days) | |
| Secondary | Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding | 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). | Up to Day 60 of each treatment period (up to 160 days) | |
| Secondary | Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding | 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). | Up to Day 60 of each treatment period (up to 160 days) | |
| Secondary | Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study | 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. | Up to Day 60 of each treatment period (up to 160 days) |