Conditions: Genital Herpes
Keywords: Herpes simplex genital herpes famciclovir valacyclovir Recurrent genital herpes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1179
Healthy volunteers: no

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 treatment with valacyclovir (500 mg capsule b.i.d).

Detailed description:

Arms:
arm 1: Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. arm 2: Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.

Interventions: intervention 1: Famciclovir intervention 2: Valacyclovir intervention 3: Placebo matching famciclovir intervention 4: Placebo matching valacyclovir
Intervention descriptions: intervention 1: Famciclovir 500 mg tablet intervention 2: Valacyclovir 500 mg capsule intervention 3: Famciclovir placebo, matching in size, color and forms of famciclovir tablet. intervention 4: Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.

Protocol document: