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

Novartis

Status and phase: Completed; Phase 4

Conditions: Genital Herpes

Treatments: Drug: Famciclovir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00477334

CFAM810A2310

Details and patient eligibility

About

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

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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463 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Famciclovir 1000 mg; twice a day for one day.

Treatment:

Drug: Famciclovir

2

Placebo Comparator group

Description:

Placebo; twice a day for one day.

Treatment:

Drug: Placebo