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

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

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 Overview

• Status: Completed
• Conditions: GENITAL HERPES
• Intervention / Treatment: Drug: Famciclovir; Drug: Aciclovir

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, RS, Brazil
      • Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
  • SP
    • Braganca Paulista, SP, Brazil
      • SPVita
    • Campinas, SP, Brazil
      • Caep Centro Avancado de Estudos E Pesquisas Ltda
    • Campinas, SP, Brazil
      • CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
    • Jau, SP, Brazil
      • CECIP - Centro de Estudos Clínicos do Interior Paulista
    • Ribeirao Preto, SP, Brazil, 14048900
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
    • Sao Paulo, SP, Brazil, 01308-060
      • Instituto Sirio Libanes de Ensino e Pesquisa
    • Sao Paulo, SP, Brazil
      • Afip - Associacao Fundo de Incentivo A Psicofarmacologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Study Director: Roberto Amazonas, MD, EMS

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Herpes Simplex Virus
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Acyclovir; Famciclovir
• Other Study ID Numbers: F125EMS1010