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

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

Purpose

This study will assess the safety and efficacy of one-day famciclovir in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir.

Condition	Intervention	Phase
Genital Herpes	Drug: Famciclovir Drug: Valacyclovir	Phase III

Drug Information available for: Famciclovir Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Novartis:

Primary Outcome Measures:

Time to healing of non-aborted genital herpes lesions in patients with recurrent genital herpes [ Time Frame: 72 hours after initiation of study medication up to Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of famciclovir as assessed by adverse events (AEs) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Proportion of patients with aborted genital herpes lesions [ Time Frame: 72 hours after initiation of study medication ] [ Designated as safety issue: No ]
Time to healing of all (non-aborted and aborted) genital herpes lesions [ Time Frame: 72 hours after initiation of study medication up to Day 14 ] [ Designated as safety issue: No ]
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 ]
Frequency of patients with a second recurrence and time to second recurrence of genital herpes [ Time Frame: Up to 6 months post first recurrence of genital herpes ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Famciclovir 1000 mg: Experimental	Drug: Famciclovir
Valacyclovir 500 mg: Active Comparator	Drug: Valacyclovir

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

Show 64 Study Locations

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 National Clinical Trials Identifier (NCT ID):

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:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CFAM810A2308
Study First Received:	March 22, 2006
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00306787 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada

Keywords provided by Novartis:

Herpes simplex
genital herpes
famciclovir
valacyclovir
Recurrent genital herpes

Study placed in the following topic categories:

Herpes Simplex
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Genital Diseases, Male
Antiviral Agents
Recurrence
Herpesviridae Infections

Virus Diseases
Genital Diseases, Female
Valacyclovir
Famciclovir
Sexually Transmitted Diseases
DNA Virus Infections

Additional relevant MeSH terms:

Herpes Simplex
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Genital Diseases, Male
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

Virus Diseases
Genital Diseases, Female
Valacyclovir
Famciclovir
Therapeutic Uses
Sexually Transmitted Diseases
DNA Virus Infections

ClinicalTrials.gov processed this record on May 07, 2009