Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Study Overview
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Brief Summary
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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
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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

Official Title
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A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 125 mg Comparing to Aciclovir 200 mg in Patients With Active Recurrent Genital Herpes

Conditions
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GENITAL HERPES

Intervention / Treatment
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* Drug: Famciclovir
* Drug: Aciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with clinical diagnosis of recurrent genital herpes; Score symptoms higher than 4; Negative pregnant urine test. Exclusion criteria: Pregnancy or risk of pregnancy. Lactation Any pathology or past medical condition that can interfere with this protocol. Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study); Patients with immunodeficiency and/or immunosuppressive disease; Hypersensitivity to components of the formula; Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Famciclovir 125 mg<br>1 tablet every 12 hours for 5 days | Drug: Famciclovir<br>* Famciclovir 125 mg every 12 hours for 5 days<br>|
| Active Comparator: Aciclovir 200 mg<br>1 tablet every 4 hours (excluding nocturnal dose) for 5 days | Drug: Aciclovir<br>* Aciclovir 200 mg every 4 hours fo 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin. | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Will be Evaluated by the Adverse Events Occurence | Adverse events will be collected and followed in order to evaluate safety and tolerability | Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes Simplex Virus