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

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 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) comparing to 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 symptoms
• Adverse events evaluation

• Drug: Famciclovir
  Famciclovir 125 mg each 12 hours for 5 days
• Drug: Aciclovir
  Aciclovir 200 mg each 4 hours fo 5 days

• Experimental: Famciclovir 125 mg
  Each 12 hours for 5 days
  Intervention: Drug: Famciclovir
• Active Comparator: Aciclovir 200 mg
  Each 4 hours for 5 days
  Intervention: Drug: Aciclovir

Inclusion criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with clinical diagnosis of recurrent genital herpes;
3. Score symptoms higher than 4;
4. Negative pregnant urine test.

Exclusion criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Any pathology or past medical condition that can interfere with this protocol.
4. Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
5. Patients with immunodeficiency and/or immunosuppressive disease;
6. Hypersensitivity to components of the formula;
7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.