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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 2-Aminopurine; Acyclovir; Famciclovir; Valacyclovir

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.