Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
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ClinicalTrials.gov Identifier: NCT01281007 |
Recruitment Status
:
Completed
First Posted
: January 21, 2011
Results First Posted
: July 7, 2015
Last Update Posted
: July 7, 2015
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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 |
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 (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 |

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
|
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of recurrent genital herpes;
- Score symptoms higher than 4;
- Negative pregnant urine test.
Exclusion criteria:
- Pregnancy or risk of pregnancy.
- Lactation
- Any pathology or past medical condition that can interfere with this protocol.
- Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
- Patients with immunodeficiency and/or immunosuppressive disease;
- Hypersensitivity to components of the formula;
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281007
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 |
Study Director: | Roberto Amazonas, MD | EMS |
Responsible Party: | EMS |
ClinicalTrials.gov Identifier: | NCT01281007 History of Changes |
Other Study ID Numbers: |
F125EMS1010 |
First Posted: | January 21, 2011 Key Record Dates |
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 |