Patient-Initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00477334

Purpose

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Condition	Intervention	Phase
Genital Herpes	Drug: Famciclovir Drug: Placebo	Phase IV

Drug Information available for: Famciclovir

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Double-Blind Study to Compare the Efficacy of Single-Day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-Initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Time to healing of non-aborted genital herpes lesions [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Safety as assessed by adverse events and laboratory abnormalities [ Time Frame: 1 year and 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	463
Study Start Date:	June 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Famciclovir oral; 1000 mg famciclovir twice a day; single treatment
2: Placebo Comparator	Drug: Placebo oral; twice a day

Eligibility

Criteria

Inclusion Criteria:

Black men or women 18 years or older
History of recurrent genital herpes with at least 4 recurrences in preceding year
Documented herpes simplex virus - 2 (HSV-2) seropositivity
Willingness to discontinue suppressive therapy during study, if applicable
Willingness and ability to comply with the study protocol

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477334

Locations

United States, Missouri
Dr. Mohammed
St. Louis, Missouri, United States, 63117

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Dalu Mohammed, Dr

Clayton Research Institute

More Information

Click here for more information on this study This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFAM810A2310
Study First Received:	May 22, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00477334
Health Authority:	United States: Food and Drug Administration; South Africa: Medicines Control Council

Keywords provided by Novartis:

Recurrent genital herpes
Black population

Study placed in the following topic categories:

Genital Diseases, Female
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Famciclovir
Herpes Genitalis

Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Male
Recurrence
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009