Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment 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

• Famciclovir (Drug): Famciclovir 125 mg every 12 hours for 5 days
• Aciclovir (Drug): Aciclovir 200 mg every 4 hours fo 5 days

Primary outcomes

• Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation [Day 5]: Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

Secondary outcomes

• Safety Will be Evaluated by the Adverse Events Occurence [Day 5]: Adverse events will be collected and followed in order to evaluate safety and tolerability

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation (Primary), Number, subjects: Famciclovir 125 mg 73; Aciclovir 200 mg 52
• Safety Will be Evaluated by the Adverse Events Occurence (Secondary)

Adverse events

Other adverse events by term

• Roberto Amazonas, MD, Study director, EMS