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Genital HerpesPhase 3NCT00306787

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

A Phase 3 study testing Famciclovir and Valacyclovir in people with Genital Herpes, run by Novartis Pharmaceuticals at 66 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d). 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 and Valacyclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,179 participants
Where
66 sitesin 4 countries
Study dates
Mar 2006to Feb 2008
Phase
Phase 3
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

  • At least 18 years old
  • History of at least 4 recurrences of genital herpes in the preceding 12 months
  • Lesions located on the external genitalia or anogenital region
  • Willing to discontinue suppressive treatment
  • Documented positive herpes simplex virus (HSV)
  • General good health, and history of normal renal function

Who cannot join

  • Women of childbearing potential not using approved form of contraceptive
  • Pregnant or nursing women
  • History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
  • Known to be immunosuppressed
  • Known to have renal dysfunction
  • Receiving anti-herpes therapy
Show all 9Show fewer
  • Known to have other genital tract disorders
  • Known to have condition which could interfere with drug absorption
  • Additional protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

66 sites in 4 countries.

66 sites in 4 countries

United States51 sites

  • Mount Vernon Clinical Research

    Atlanta, Georgia, 30328

  • Benchmark Research

    Austin, Texas, 78705

  • SNBL Clinical Pharmacology Center

    Baltimore, Maryland, 21201

  • Deaconess Billings Clinic Research Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Visions Clinical Research

    Boynton Beach, Florida, 33437

  • Providence Clinical Research

    Burbank, California, 91505

  • Novartis Investigative Site

    Chandler, Arizona, 85225

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • S. Carolina Clinical Research Center

    Columbia, South Carolina, 29201

  • Renaissance Clinical Research and Hypertension Clinic

    Dallas, Texas, 75235

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio, 45439

  • Barbara Davis Center

    Denver, Colorado, 80262

  • Medisphere Medical Research Center, LLC.

    Evansville, Indiana, 47714

  • Research Inc.

    Florence, South Carolina, 29501

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Center for Clinical Studies (TX Medical Center)

    Houston, Texas, 77030

  • Center for Clinical Studies

    Houston, Texas, 77058

  • Indiana University Infectious Disease Research Group

    Indianapolis, Indiana, 46202

  • NEA Women's Clinic

    Jonesboro, Arkansas, 72401

  • Cohen & Womack, P.C.

    Lakewood, Colorado, 80228

  • The Woman's Clinic

    Little Rock, Arkansas, 72205

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Common Wealth Biomedical Research

    Madisonville, Kentucky, 42431

  • International Research Association LLC

    Miami, Florida, 33156

  • Lynne Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Heartland Clinical Research, Inc.

    Omaha, Nebraska, 68134

  • Orlando Clinical Research Ctr.

    Orlando, Florida, 32809

  • Avancia Research

    Pembroke Pines, Florida, 33024

  • University Clinical Research, Inc.

    Pembroke Pines, Florida, 33024

  • Paddington Testing Co. Inc

    Philadelphia, Pennsylvania, 19103

  • Women's Health Research

    Phoenix, Arizona, 85015

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Westover Heights Clinic

    Portland, Oregon, 97210

  • UNC Clinical Research.

    Raleigh, North Carolina, 27607

  • Clinical Trials of Virginia, Inc.

    Richmond, Virginia, 23225

  • Sacramento Research Medical Group

    Sacramento, California, 95825

  • North California Research Corp.

    Sacramento, California, 95831

  • University of Utah-School of Medicine (Div. of Inf. Disease)

    Salt Lake City, Utah, 84132

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Conant Research

    San Francisco, California, 94114

  • Salt Lake Women's Center/Physician's Research Options

    Sandy City, Utah, 84070

  • University of Washington, Virology Research Clinic

    Seattle, Washington, 98122

  • Palmetto Clinical Trial Services, LLC

    Simpsonville, South Carolina, 29681

  • Future Care Studies

    Springfield, Massachusetts, 01107

  • Clayton Research Institute

    St Louis, Missouri, 63117

  • Liberty Research Center

    Tacoma, Washington, 98405

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Hawthorne Medical Research, Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada9 sites

  • Novartis Investigational Site

    Edmonton, Alberta, T6G 2B6

  • Novartis Investigational Site

    Laval, Quebec, H7X 3S5

  • Novartis Investigational Site

    Markham, Ontario, L3P 1A8

  • Novartis Investigational Site

    Montreal, Quebec, H2K 4L5

  • Novartis Investigational Site

    Montreal, Quebec, H3H IV4

  • Novartis Investigational Site

    Ottawa, Ontario, K1S 0G8

  • Novartis Investigational Site

    Sainte-Foy, Quebec, G1V 4G2

  • Novartis Investigational Site

    Vancouver, British Columbia, V6Z 2C7

  • Novartis Investigational Site

    Winnipeg, Manitoba, R3E 0W3

Other trials in Canada

Germany5 sites

  • Novartis Investigational Site

    Augsburg, D-86179

  • Novartis Investigational Site

    Berlin

  • Novartis Investigational Site

    Freiburg im Breisgau, 79106

  • Novartis Investigational Site

    Rostock, D-18055

  • Novartis Investigational Site

    Wolfsburg, D-38440

Other trials in Germany

Australia1 site

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010

Other trials in Australia

About this study

Official title: A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

Conditions
Genital Herpes
Being tested
Famciclovir, Valacyclovir, Placebo matching famciclovir, Placebo matching valacyclovir
Keywords
Herpes simplex, genital herpes, famciclovir, valacyclovir, Recurrent genital herpes
Medical subject headings
Herpes Genitalis, Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FamciclovirDrug

    Also called Famvir

    Famciclovir 500 mg tablet

  • ValacyclovirDrug

    Also called Valtrex

    Valacyclovir 500 mg capsule

  • Placebo matching famciclovirDrug

    Famciclovir placebo, matching in size, color and forms of famciclovir tablet.

  • Placebo matching valacyclovirDrug

    Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.

Study groups in NCT00306787
Study groupRoleWhat they receive
FamciclovirExperimentalPatients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
Receives: Drug: Famciclovir; Drug: Placebo matching valacyclovir
ValacyclovirActive comparatorPatients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
Receives: Drug: Valacyclovir; Drug: Placebo matching famciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions

    Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.

    Measured: 72 hours after initiation of study medication up to Day 20

Secondary outcomes (5)

  1. Percentage of Participants With Aborted Genital Herpes Lesions

    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.

    Measured: 72 hours after initiation of study medication up to Day 20

  2. Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions

    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.

    Measured: 72 hours after initiation of study medication up to Day 20

  3. Time to Resolution of Symptoms Associated With Recurrent Genital Herpes

    Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.

    Measured: 72 hours after initiation of study medication up to Day 20

  4. Number of Patients With a Second Recurrence of Genital Herpes

    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.

    Measured: Up to 6 months after investigator assessed healing of first recurrence of genital herpes

  5. Time to a Second Recurrence of Genital Herpes

    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:

    1. From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or
    2. From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.

    Measured: Up to 6 months after investigator assessed healing of first recurrence of genital herpes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00306787
Sponsor's protocol ID
CFAM810A2308
Status last verified
Jun 2011
First submitted
22 Mar 2006
Last updated
30 Jun 2011

Publications

  • Bodsworth N, Fife K, Koltun W, Tyring S, Abudalu M, Prichard M, Hamed K. Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Curr Med Res Opin. 2009 Feb;25(2):483-7. doi: 10.1185/03007990802664678.

    PubMed 19192993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Famciclovir and Valacyclovir in people with Genital Herpes, run by Novartis Pharmaceuticals at 66 sites in 4 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 6 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 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Canada, Germany, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Jun 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: 72 hours after initiation of study medication up to Day 20). 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 NCT00306787, 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 30 Jun 2011.

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