Status:
COMPLETED
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Genital Herpes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
1179 Patients enrolled
Trial Details
Trial ID
NCT00306787
Start Date
March 1 2006
End Date
February 1 2008
Last Update
June 30 2011
Active Locations (66)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Novartis Investigative Site
Chandler, Arizona, United States, 85225
3
Women's Health Research
Phoenix, Arizona, United States, 85015
4
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States, 85712