We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With 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.
 
ClinicalTrials.gov Identifier: NCT00306787
Recruitment Status : Completed
First Posted : March 24, 2006
Results First Posted : June 17, 2011
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
Novartis

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Genital Herpes Drug: Famciclovir Drug: Valacyclovir Drug: Placebo matching famciclovir Drug: Placebo matching valacyclovir Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Famciclovir
Patients 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.
 Drug: Famciclovir
Famciclovir 500 mg tablet
Other Name: Famvir

Drug: Placebo matching valacyclovir
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Active Comparator: Valacyclovir
Patients 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.
 Drug: Valacyclovir
Valacyclovir 500 mg capsule
Other Name: Valtrex

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]
    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.

  2. Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]
    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.

  3. Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 72 hours after initiation of study medication up to Day 20 ]
    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.

  4. Number of Patients With a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first 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.

  5. Time to a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00306787


Locations
Show Show 66 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00306787    
Other Study ID Numbers: CFAM810A2308
First Posted: March 24, 2006    Key Record Dates
Results First Posted: June 17, 2011
Last Update Posted: June 30, 2011
Last Verified: June 2011
Keywords provided by Novartis:
Herpes simplex
genital herpes
famciclovir
valacyclovir
Recurrent genital herpes
Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Communicable Diseases
Valacyclovir
Famciclovir
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action