Infections, HerpesviridaePhase 4NCT00116844
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.
A Phase 4 study testing Valaciclovir in people with Infections, Herpesviridae, run by GlaxoSmithKline at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections, Herpesviridae
- What is being tested?
- Valaciclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 17 sitesUnited States
- Study dates
- 29 Mar 2005to 10 Jan 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
Who cannot join
- have active lesions consistent with genital herpes.
- previous history of symptomatic genital herpes.
- history of recurrent, undiagnosed symptoms consistent with genital herpes.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Carmichael, California, 95608
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Davis, California, 95616
GSK Investigational Site
Fort Wayne, Indiana, 46804
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
New York, New York, 10011
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Sacramento, California, 92585
GSK Investigational Site
Salt Lake City, Utah, 84132
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Stony Brook, New York, 11794
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Tulsa, Oklahoma, 74104
About this study
Official title: Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
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.
- Conditions
- Infections, Herpesviridae
- Being tested
- Valaciclovir, Placebo
- Keywords
- viral shedding, Recurrent, herpes, genital herpes
- Medical subject headings
- Herpesviridae Infections, Recurrence, Herpes Simplex, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValaciclovirDrug
Valtrex 1g once daily
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: VALTREX 1 g once daily, Placebo | Experimental | VALTREX 1 g once daily, Placebo Receives: Drug: Valaciclovir; Drug: Placebo |
| Sequence 2: Placebo, VALTREX 1 g once daily | Experimental | Placebo, VALTREX 1 g once daily Receives: Drug: Valaciclovir; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 60 of each treatment period (up to 160 days)
Secondary outcomes (5)
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.
Measured: Up to Day 60 of each treatment period (up to 160 days)
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).
Measured: Up to Day 60 of each treatment period (up to 160 days)
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).
Measured: Up to Day 60 of each treatment period (up to 160 days)
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).
Measured: Up to Day 60 of each treatment period (up to 160 days)
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.
Measured: Up to Day 60 of each treatment period (up to 160 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study start29 Mar 2005
- Primary completion10 Jan 2006
- Study completion10 Jan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, HerpesviridaeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116844
- Sponsor's protocol ID
- VLX103596
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2005
- Last updated
- 12 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
- ClinicalTrials.gov ID
- NCT00116844
- Acronym / sponsor ID
- VLX103596
- Conditions
- Infections, Herpesviridae
- Keywords
- viral shedding, Recurrent, herpes, genital herpes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2005 (actual)
- Primary completion
- 10 Jan 2006 (actual)
- Study completion
- 10 Jan 2006 (actual)
- First posted
- 1 Jul 2005 (estimated)
- Results
- Posted 12 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: VALTREX 1 g once daily, Placebo | Experimental | Drug: Valaciclovir, Drug: PlaceboVALTREX 1 g once daily, Placebo |
| Sequence 2: Placebo, VALTREX 1 g once daily | Experimental | Drug: Valaciclovir, Drug: PlaceboPlacebo, VALTREX 1 g once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
Key exclusion criteria (3 listed)
- have active lesions consistent with genital herpes.
- previous history of symptomatic genital herpes.
- history of recurrent, undiagnosed symptoms consistent with genital herpes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValaciclovirValtrex 1g once daily | Drug | Sequence 1: VALTREX 1 g once daily, Placebo, Sequence 2: Placebo, VALTREX 1 g once daily |
| Placeboplacebo | Drug | Sequence 1: VALTREX 1 g once daily, Placebo, Sequence 2: Placebo, VALTREX 1 g once daily |
Primary outcome
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.
5 secondary outcomes
Mean Percent Days of Total HSV-2 Shedding
Time frame: Up to Day 60 of each treatment period (up to 160 days)
Number of Participants With no Shedding
Time frame: Up to Day 60 of each treatment period (up to 160 days)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valaciclovir in people with Infections, Herpesviridae, run by GlaxoSmithKline at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.