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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
GENITAL HERPES	Drug: Famciclovir; Drug: Aciclovir	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	July 2012
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	March 2015

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
Porto Alegre, RS, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
SPVita
Braganca Paulista, SP, Brazil
Caep Centro Avancado de Estudos E Pesquisas Ltda
Campinas, SP, Brazil
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
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

EMS

Investigators

Study Director:	Roberto Amazonas, MD	EMS

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	EMS
ClinicalTrials.gov Identifier:	NCT01281007 History of Changes
Other Study ID Numbers:	F125EMS1010
First Posted:	January 21, 2011
Results First Posted:	July 7, 2015
Last Update Posted:	July 7, 2015
Last Verified:	July 2015

Keywords provided by EMS:

Herpes Simplex Virus

Additional relevant MeSH terms:

Herpes Genitalis; Herpes Simplex; 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; Antimetabolites; Molecular Mechanisms of Pharmacological Action