Genital HerpesPhase 4NCT00129818
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
A Phase 4 study testing Famciclovir in people with Genital Herpes, run by Novartis at 7 sites in United States.
Trial summary
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genital Herpes
- What is being tested?
- Famciclovir
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Jul 2004to Oct 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
- Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes
Who cannot join
- Pregnancy
- History of renal dysfunction
- Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
- Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
IU Center for Clinical STD Research
Indianapolis, Indiana, 46202
Lynne Health Science Institute
Oklahoma City, Oklahoma, 73112
Orlando Clinical Research Center
Orlando, Florida, 32809
Westover Heights Clinic
Portland, Oregon, 97210
UNC Clinical Research - Raleigh
Raleigh, North Carolina, 27607
University of Washington - Virology Research Clinic
Seattle, Washington, 98122
About this study
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.
- Conditions
- Genital Herpes
- Being tested
- Famciclovir
- Keywords
- Genital herpes, viral shedding, famciclovir, Symptomatic genital herpes, Asymptomatic genital herpes
- Medical subject headings
- Herpes Genitalis
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.
Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
Secondary outcomes (5)
reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2005
- Study completionOct 2005
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.
- 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
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
- NCT00129818
- Sponsor's protocol ID
- CFAM810A2404
- Status last verified
- Apr 2012
- First submitted
- 11 Aug 2005
- Last updated
- 27 Apr 2012
- Results posted
- No
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 Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
- ClinicalTrials.gov ID
- NCT00129818
- Acronym / sponsor ID
- CFAM810A2404
- Conditions
- Genital Herpes
- Keywords
- Genital herpes, viral shedding, famciclovir, Symptomatic genital herpes, Asymptomatic genital herpes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Aug 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.
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes
Key exclusion criteria (4 listed)
- Pregnancy
- History of renal dysfunction
- Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
- Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
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
Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
5 secondary outcomes
reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
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.
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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.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
7 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 Famciclovir in people with Genital Herpes, run by Novartis at 7 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 1 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 7 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?
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?
Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions. The study lists 2 primary outcomes in all. 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 27 Apr 2012.