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

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 (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).

Intervention(s) in this Clinical Trial

• Drug: Famciclovir
  • Famciclovir 500 mg tablet
• Drug: Valacyclovir
  • Valacyclovir 500 mg capsule
• Drug: Placebo matching famciclovir
  • Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
• Drug: Placebo matching valacyclovir
  • Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary 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
    Safety Issue?: No

Secondary Measures

• Percentage of Participants With Aborted Genital Herpes Lesions
  • Time Frame: 72 hours after initiation of study medication up to Day 20
    Safety Issue?: No
• 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
    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
• 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
    Safety Issue?: No
• Time to a Second Recurrence of Genital Herpes
  • Time Frame: Up to 6 months after investigator assessed healing of 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 Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

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