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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01281007
First received: January 20, 2011
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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
GENITAL HERPES
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


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (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:

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
  Eligibility

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

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

Contacts
Contact: Pesquisa Clínica 55 11 38879851 pesquisa.clinica@ems.com.br

Locations
Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda Recruiting
Porto Alegre, RS, Brazil
Contact: Carlos Isaia Filho, MD         
Principal Investigator: Carlos Isaia Filho, MD         
Hospital Sao Lucas da PUCRS Recruiting
Porto Alegre, RS, Brazil, 90610000
Contact: Carlos Cairoli, MD         
Principal Investigator: Carlos Cairoli, MD         
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil
Contact: Paulo Naud, MD         
Principal Investigator: Paulo Naud, MD         
SPVita Recruiting
Braganca Paulista, SP, Brazil
Contact: Mateus Kawasaki, MD         
Principal Investigator: Mateus Kawasaki, MD         
Caep Centro Avancado de Estudos E Pesquisas Ltda Recruiting
Campinas, SP, Brazil
Contact: Ulisses A Rocha, MD         
Principal Investigator: Ulisses A Rocha, MD         
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas Recruiting
Campinas, SP, Brazil
Contact: Luiz G Bahamondes, MD         
Principal Investigator: Luiz G Bahamondes, MD         
CECIP - Centro de Estudos Clínicos do Interior Paulista Recruiting
Jau, SP, Brazil
Contact: Paula U TOKUNAGA, MD         
Principal Investigator: Paula U Tokunaga, MD         
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Recruiting
Ribeirao Preto, SP, Brazil, 14048900
Contact: Silvana M Quintana, MD    55 16 3602 2956    quintana@fmrp.usp.br   
Principal Investigator: Silvana M Quintana, MD         
Instituto Sirio Libanes de Ensino e Pesquisa Recruiting
Sao Paulo, SP, Brazil, 01308-060
Contact: Esper Kallas, MD    55 11 3155.8800      
Principal Investigator: Esper Kallas, MD         
Afip - Associacao Fundo de Incentivo A Psicofarmacologia Recruiting
Sao Paulo, SP, Brazil
Contact: Helena H Campos, MD    55 11 5908 7081      
Principal Investigator: Helena H Campos, MD         
Hospital das Clínicas Recruiting
São Paulo, Brazil
Contact: Lana Maria de Aguiar, MD         
Principal Investigator: Lana Maria de Aguiar, MD         
Hospital e Maternidade Leonor Mendes de Barros Recruiting
São Paulo, Brazil
Contact: Corintio Manriani Neto, MD         
Principal Investigator: Corintio Mariani Neto, MD         
Centro de Referência e Treinamento DST/AIDS Recruiting
São Paulo, Brazil
Contact: Roberto José Carvalho da Silva, MD         
Principal Investigator: Roberto José Carvalho da Silva, MD         
Sponsors and Collaborators
EMS
Investigators
Study Director: Felipe Pinho, 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
Last Updated: October 7, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Herpes Simplex Virus

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

ClinicalTrials.gov processed this record on September 22, 2014