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”

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.

Study Type: Interventional

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

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Famciclovir
• Drug: Valacyclovir

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Famciclovir 1000 mg
• Active Comparator: Valacyclovir 500 mg

Primary 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
    Safety Issue?: No

Secondary Measures

• Safety of famciclovir as assessed by adverse events (AEs)
  • Time Frame: Throughout the study
    Safety Issue?: Yes
• Proportion of patients with aborted genital herpes lesions
  • Time Frame: 72 hours after initiation of study medication
    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
    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
    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
    Safety Issue?: No

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.

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 Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00306787

Study ID Number: CFAM810A2308

ClinicalTrials.gov Identifier: NCT00306787

Health Authority: United States: Food and Drug Administration

eRecruitment