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”

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

Study Type: Interventional

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

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: Famciclovir
  • oral; 1000 mg famciclovir twice a day; single treatment
• Drug: Placebo
  • oral; twice a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Time to healing of non-aborted genital herpes lesions
  • Time Frame: 21 days
    Safety Issue?: No

Secondary Measures

• • Safety as assessed by adverse events and laboratory abnormalities
  • Time Frame: 1 year and 5 weeks
    Safety Issue?: Yes

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:

• Pregnant or breastfeeding women
• Women of childbearing potential not using accepted methods of contraception
• Hypersensitivity to famciclovir or drugs with similar chemical structures
• Renal dysfunction
• Hepatic diseases Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Dalu Mohammed, Dr Principal Investigator Clayton Research Institute  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00477334

Study ID Number: CFAM810A2310

ClinicalTrials.gov Identifier: NCT00477334

Health Authority: United States: Food and Drug Administration

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