Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: 2-Aminopurine; Famciclovir

Criteria

Inclusion Criteria:

• Black men or women 18 years or older

• History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy

• Documented herpes simplex virus type 2 (HSV-2) seropositivity

• Willingness to discontinue suppressive therapy during study, if applicable

• Willingness and ability to comply with the study protocol

Exclusion Criteria:

• Pregnant or breastfeeding women

• Women of childbearing potential not using accepted methods of contraception

• Hypersensitivity to famciclovir or drugs with similar chemical structures

• Renal dysfunction

• Known or suspected to have decompensated liver disease

• Known to have gastrointestinal malabsorption

• Known to be immunocompromised

• Known to be hypersensitive to ingredients in study medication

• Other protocol-defined inclusion/exclusion criteria may apply