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Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171990
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 15, 2013
Information provided by:

Brief Summary:

This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes.

This study is not recruiting patients in the United States.

Condition or disease Intervention/treatment Phase
Recurrent Genital Herpes Drug: Famciclovir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
Study Start Date : January 2003
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes
Drug Information available for: Famciclovir

Primary Outcome Measures :
  1. Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.

Secondary Outcome Measures :
  1. Safety and tolerability assessed by AEs.
  2. Time between recurrences of genital herpes.
  3. Proportion of aborted (i.e. lesions did not appear)genital herpes recurrences. Change from baseline in symptoms or impairment. Change form baseline in functioning or disability.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Diagnosis of genital herpes
  • Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months

Exclusion Criteria:

  • - Currently taking suppressive herpes antiviral therapy
  • Females who are pregnant, breast feeding or planning to become pregnant during study
  • History of allergy to famciclovir or similar products (e.g. aciclovir, valaciclovir)

Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171990

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Novartis Investigative Site
North Ryde, Australia
Sponsors and Collaborators
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Study Chair: Novartis Pharma AG Novartis Pharmaceuticals

Layout table for additonal information Identifier: NCT00171990    
Other Study ID Numbers: CFAM810AAU01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by Novartis:
genital herpes
Additional relevant MeSH terms:
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Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action