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

EMS

Status and phase: Completed; Phase 3

Conditions: GENITAL HERPES

Treatments: Drug: Aciclovir; Drug: Famciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01281007

F125EMS1010

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Famciclovir 125 mg

Experimental group

Description:

1 tablet every 12 hours for 5 days

Treatment:

Drug: Famciclovir

Aciclovir 200 mg

Active Comparator group

Description:

1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Treatment:

Drug: Aciclovir