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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 20, 2011
Last updated: July 3, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Drug: Famciclovir
Drug: Aciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

Secondary Outcome Measures:
  • Safety Will be Evaluated by the Adverse Events Occurence [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability

Enrollment: 150
Study Start Date: July 2012
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:


  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281007

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
Porto Alegre, RS, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
Braganca Paulista, SP, Brazil
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
Campinas, SP, Brazil
Caep Centro Avancado de Estudos E Pesquisas Ltda
Campinas, SP, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jau, SP, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirao Preto, SP, Brazil, 14048900
Instituto Sirio Libanes de Ensino e Pesquisa
Sao Paulo, SP, Brazil, 01308-060
Afip - Associacao Fundo de Incentivo A Psicofarmacologia
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Study Director: Roberto Amazonas, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01281007     History of Changes
Other Study ID Numbers: F125EMS1010
Study First Received: January 20, 2011
Results First Received: May 29, 2015
Last Updated: July 3, 2015
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Herpes Simplex Virus

Additional relevant MeSH terms:
Herpes Genitalis
DNA Virus Infections
Genital Diseases, Female
Genital Diseases, Male
Herpes Simplex
Herpesviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 06, 2015