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

GENITAL HERPES Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281007
• Other study ID #: F125EMS1010
• Status: Completed
• Phase: Phase 3
• Start date: July 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GENITAL HERPES
• Herpes Genitalis

Intervention

Drug:
• Famciclovir
Famciclovir 125 mg every 12 hours for 5 days
• Aciclovir
Aciclovir 200 mg every 4 hours fo 5 days

Locations

Country	Name	City	State
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	Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda	Porto Alegre	RS
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo	Ribeirao Preto	SP
Brazil	Afip - Associacao Fundo de Incentivo A Psicofarmacologia	Sao Paulo	SP
Brazil	Instituto Sirio Libanes de Ensino e Pesquisa	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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