Recurrent Genital Herpes (RGH)Phase 4NCT00219310
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
A Phase 4 study testing Famciclovir in people with Recurrent Genital Herpes (RGH), run by Novartis at 1 site in United States.
Trial summary
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Genital Herpes (RGH)
- What is being tested?
- Famciclovir
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jun 2005
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.
- Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR).
- Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes
Who cannot join
- • Female patients who are pregnant or breast-feeding.
- Current, history or suspicion of liver disease or kidney disease.
- HIV infected (as confirmed by positive HIV serology).
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.
- Conditions
- Recurrent Genital Herpes (RGH)
- Being tested
- Famciclovir
- Keywords
- Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
- Medical subject headings
- Herpes Genitalis, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamciclovirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
Secondary outcomes (4)
Change in total score of the Recurrent Genital Herpes Quality of Life.
Safety assessed by adverse events.
Time to first recurrence of genital herpes.
Number of genital herpes recurrences confirmed by PCR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Genital Herpes (RGH)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219310
- Sponsor's protocol ID
- CFAM810AUS07
- Status last verified
- Apr 2012
- First submitted
- 21 Sep 2005
- Last updated
- 27 Apr 2012
- Results posted
- No
Publications
Bartlett BL, Tyring SK, Fife K, Gnann JW Jr, Hadala JT, Kianifard F, Berber E. Famciclovir treatment options for patients with frequent outbreaks of recurrent genital herpes: the RELIEF trial. J Clin Virol. 2008 Oct;43(2):190-5. doi: 10.1016/j.jcv.2008.06.004. Epub 2008 Jul 14.
PubMed 18621575
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT00219310
- Acronym / sponsor ID
- CFAM810AUS07
- Conditions
- Recurrent Genital Herpes (RGH)
- Keywords
- Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 22 Sep 2005 (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.
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.
Key exclusion criteria (4 listed)
- • Female patients who are pregnant or breast-feeding.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Famciclovir | Drug | – |
Primary outcome
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
4 secondary outcomes
Change in total score of the Recurrent Genital Herpes Quality of Life.
Safety assessed by adverse events.
Time to first recurrence of genital herpes.
Number of genital herpes recurrences confirmed by PCR.
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 27 Apr 2012.
- Derived from this study: PubMed 18621575Bartlett BL, Tyring SK, Fife K, Gnann JW Jr, Hadala JT, Kianifard F, Berber E. Famciclovir treatment options for patients with frequent outbreaks of recurrent genital herpes: the RELIEF trial. J Clin Virol. 2008 Oct;43(2):190-5. doi: 10.1016/j.jcv.2008.06.004. Epub 2008 Jul 14.
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.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Famciclovir in people with Recurrent Genital Herpes (RGH), run by Novartis at 1 site 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 3 inclusion and 4 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00219310, which also lists 1 linked publication.
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 27 Apr 2012; AzTrials last refreshed its copy on 31 Oct 2026.