Conditions: GENITAL HERPES
Keywords: Herpes Simplex Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.

This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.

Detailed description:
STUDY DESIGN

* Open-label, prospective, parallel group, intent to treat trial
* Experiment duration: 5 days
* 2 visits (days 1, and 5)
* Reduction of symptoms
* Adverse events evaluation

Arms:
arm 1: 1 tablet every 12 hours for 5 days arm 2: 1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Interventions: intervention 1: Famciclovir intervention 2: Aciclovir
Intervention descriptions: intervention 1: Famciclovir 125 mg every 12 hours for 5 days intervention 2: Aciclovir 200 mg every 4 hours fo 5 days

Protocol document: