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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00306787

Purpose

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	Intervention	Phase
Genital Herpes	Drug: Famciclovir Drug: Valacyclovir Drug: Placebo matching famciclovir Drug: Placebo matching valacyclovir	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes Herpes Simplex

Drug Information available for: Famciclovir Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

Percentage of Participants With Aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]
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.

Enrollment:	1179
Study Start Date:	March 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306787

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Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

eRecruitment This link exits the ClinicalTrials.gov site

No publications provided by Novartis

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

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.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00306787 History of Changes
Other Study ID Numbers:	CFAM810A2308
Study First Received:	March 22, 2006
Results First Received:	August 20, 2009
Last Updated:	June 28, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

Herpes simplex
genital herpes
famciclovir
valacyclovir
Recurrent genital herpes

Additional relevant MeSH terms:

Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Famciclovir

Valacyclovir
Acyclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012