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

Completed · Phase 3 · Has a placebo group

Conditions studied: Genital Herpes

In brief

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).

Key facts

Study ID

NCT00306787

Run by

Novartis Pharmaceuticals

People needed

1179

Starts

2006-03-01

Expected to finish

2008-02-01

Last updated by the study team

2011-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Woman's Clinic — Little Rock, Arkansas, United States
• Providence Clinical Research — Burbank, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Sacramento Research Medical Group — Sacramento, California, United States
• North California Research Corp. — Sacramento, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Conant Research — San Francisco, California, United States
• Barbara Davis Center — Denver, Colorado, United States
• Cohen & Womack, P.C. — Lakewood, Colorado, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• International Research Association LLC — Miami, Florida, United States
• Orlando Clinical Research Ctr. — Orlando, Florida, United States
• Avancia Research — Pembroke Pines, Florida, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Mount Vernon Clinical Research — Atlanta, Georgia, United States
• Medisphere Medical Research Center, LLC. — Evansville, Indiana, United States
• Indiana University Infectious Disease Research Group — Indianapolis, Indiana, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Common Wealth Biomedical Research — Madisonville, Kentucky, United States
• SNBL Clinical Pharmacology Center — Baltimore, Maryland, United States
• Future Care Studies — Springfield, Massachusetts, United States
• Clayton Research Institute — St Louis, Missouri, United States
• NEA Women's Clinic — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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