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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Famciclovir 125 mg every 12 hours for 5 days
Aciclovir 200 mg every 4 hours fo 5 days
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
SPVita
Bragança Paulista, São Paulo, Brazil
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Time frame: Day 5
Safety Will be Evaluated by the Adverse Events Occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time frame: Day 5
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