Genital HerpesPhase 4NCT00477334
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
A Phase 4 study testing Famciclovir in people with Genital Herpes, run by Novartis at 43 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 463 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Jun 2007to Mar 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black men or women 18 years or older
- History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
- Documented herpes simplex virus type 2 (HSV-2) seropositivity
- Willingness to discontinue suppressive therapy during study, if applicable
- Willingness and ability to comply with the study protocol
Who cannot join
- Pregnant or breastfeeding women
- Women of childbearing potential not using accepted methods of contraception
- Hypersensitivity to famciclovir or drugs with similar chemical structures
- Renal dysfunction
- Known or suspected to have decompensated liver disease
- Known to have gastrointestinal malabsorption
Show all 9Show fewer
- Known to be immunocompromised
- Known to be hypersensitive to ingredients in study medication
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States33 sites
Millennium Clinical Trials, LLC
Arlington, Virginia, 22203
Perimeter Institute for Clinical Research Inc. ("PICR")
Atlanta, Georgia, 30338
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, 30912
Miray Medical Center
Brockton, Massachusetts, 02301
Providence Clinical Research
Burbank, California, 91505
Metrolina Internal Medicine Internal Medicine Research
Charlotte, North Carolina, 28204
Clinical Trials Management LLC
Covington, Louisiana, 70433
Soapstone Center for Clinical Research
Decatur, Georgia, 30034
Private Practice
Fort Worth, Texas, 76110
Peters Medical Research
High Point, North Carolina, 27262
Medical Research Centers of South Florida, Inc.
Hollywood, Florida, 33021
R/D Clinical Research, Inc
Houston, Texas, 77074
Alia Clinical Research, INC
Huntington Park, California, 90255
First Coast Primary Care Minority Physicians Research Alliance
Jacksonville, Florida, 32208
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101
Dermatology Research Associates
Los Angeles, California, 90045
Women's Care Center, PLC: Research Memphis Associates
Memphis, Tennessee, 38119
AppleMed Research Inc.
Miami, Florida, 33155
International Research Associates, LLC
Miami, Florida, 33156
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
North Miami, Florida, 33161
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
UNC Clinical Research
Raleigh, North Carolina, 27607
Sun Research Institute
San Antonio, Texas, 78205
The Conant Foundation Quest Diagnostics
San Francisco, California, 94114
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118
Pearl Medical Group, PLLC
Southfield, Michigan, 48075
Dr. Mohammed
St Louis, Missouri, 63117
International Research Center
Towson, Maryland, 21286
Planned Parenthood of Arkansas and Eastern Oklahoma
Tulsa, Oklahoma, 74105
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
South Africa10 sites
Josha Research
Bloemfontein
Prime Cure Medicentre
Durban
Umkomaas Clinical Research Site
eMkhomazi
Drs. Essack and Mitha
Johannesburg
Medunsa Clinical Research Unit (MeCRU)
Medunsa
Bertoni Mercy Clinic
Mmakau Village GA Rankuwa
Global Clinical Trials
Port Elizabeth
Eastmed Clinical Trial Centre/Eastmed Medical Centre
Pretoria
Setshaba Research Centre
Shoshanguve
Drs. AE and QE Bhorat
Soweto
About this study
Official title: A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
- Conditions
- Genital Herpes
- Being tested
- Famciclovir, Placebo
- Keywords
- Recurrent genital herpes, Black population
- 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
Also called Famvir
oral; two 500 mg tablets twice a day; single day treatment
PlaceboDrug
oral; two tablets twice a day; single day treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Famciclovir 1000 mg; twice a day for one day. Receives: Drug: Famciclovir |
| 2 | Placebo comparator | Placebo; twice a day for one day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).
Measured: 21 days
Secondary outcomes (7)
Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
Measured: 21 days
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
Kaplan-Meier estimation.
Measured: 21 days
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.
Measured: 72 hour after initiation of study medication up to 21 days
Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period
Number of participants with a second recurrence of genital herpes in the follow-up period.
Measured: 6 months
Time to Second Recurrence of Genital Herpes
Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.
Measured: 6 months
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment
The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.
Measured: Baseline, Day 2
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment
The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.
SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)
Measured: Baseline, Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2009
- Study completionMar 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dalu Mohammed, Dr, Principal investigator, Clayton Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477334
- Sponsor's protocol ID
- CFAM810A2310
- Status last verified
- Mar 2011
- First submitted
- 22 May 2007
- Last updated
- 28 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.
PubMed 20070143
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients
- ClinicalTrials.gov ID
- NCT00477334
- Acronym / sponsor ID
- CFAM810A2310
- Conditions
- Genital Herpes
- Keywords
- Recurrent genital herpes, Black population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 May 2007 (estimated)
- Results
- Posted 16 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FamciclovirFamciclovir 1000 mg; twice a day for one day. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo; twice a day for one day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Black men or women 18 years or older
- History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
- Documented herpes simplex virus type 2 (HSV-2) seropositivity
- Willingness to discontinue suppressive therapy during study, if applicable
- Willingness and ability to comply with the study protocol
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women
- Women of childbearing potential not using accepted methods of contraception
- Hypersensitivity to famciclovir or drugs with similar chemical structures
- Renal dysfunction
- Known or suspected to have decompensated liver disease
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 |
|---|---|---|
| FamciclovirAlso: Famviroral; two 500 mg tablets twice a day; single day treatment | Drug | 1 |
| Placebooral; two tablets twice a day; single day treatment | Drug | 2 |
Primary outcome
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Time frame: 21 days
Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).
7 secondary outcomes
Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
Time frame: 21 days
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
Time frame: 21 days
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Time frame: 72 hour after initiation of study medication up to 21 days
Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period
Time frame: 6 months
Time to Second Recurrence of Genital Herpes
Time frame: 6 months
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment
Time frame: Baseline, Day 2
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment
Time frame: Baseline, Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20070143Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.
- Click here for more information on this studyLink provided by the sponsor.
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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.
Dalu Mohammed, Dr principal investigator
Clayton Research Institute
43 sites in 2 countries: 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 43 sites in 2 countries.
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 5 inclusion and 9 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 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, South Africa. 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. Some participants in this study may receive a placebo. 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 16 Mar 2011). 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?
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions (time frame: 21 days). 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 NCT00477334, 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 28 Mar 2011.