Genital HerpesNCT01390805
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)
An observational study of Genital Herpes, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Genital Herpes
- What is being tested?
- Valaciclovir Hydrochloride.
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese subjects with recurrent genital herpes
Who may be able to join
- Subjects who started suppressive therapy for recurrent genital herpes for the first time
Who cannot join
- Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
About this study
The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.
- Conditions
- Genital Herpes
- Being tested
- Valaciclovir Hydrochloride.
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valaciclovir Hydrochloride.Drug
| Study group | Role | What they receive |
|---|---|---|
| Subjects with recurrent genital herpes | Not described Receives: Drug: Valaciclovir Hydrochloride. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startNov 2006
- Primary completionApr 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 462 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
- NCT01390805
- Sponsor's protocol ID
- 112319
- Status last verified
- May 2017
- First submitted
- 7 Jul 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)
- ClinicalTrials.gov ID
- NCT01390805
- Acronym / sponsor ID
- 112319
- Conditions
- Genital Herpes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with recurrent genital herpes | – | Drug: Valaciclovir Hydrochloride. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese subjects with recurrent genital herpes
Key inclusion criteria (1 listed)
- Subjects who started suppressive therapy for recurrent genital herpes for the first time
Key exclusion criteria (1 listed)
- Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
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 |
|---|---|---|
| Valaciclovir Hydrochloride. | Drug | Subjects with recurrent genital herpes |
Primary outcome
The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Herpes, run by GlaxoSmithKline.
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 1 inclusion and 1 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir (time frame: 1 year). 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 16 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.