Clinical trial NCT01281007: Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GENITAL HERPES
Keywords: Herpes Simplex Virus
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
timeFrame: Day 5
Secondary outcomes:
measure: Safety Will be Evaluated by the Adverse Events Occurence
timeFrame: Day 5
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Braganca Paulista
country: Brazil
facility: SPVita
state: SP
city: Campinas
country: Brazil
facility: Caep Centro Avancado de Estudos E Pesquisas Ltda
state: SP
city: Campinas
country: Brazil
facility: CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
state: SP
city: Jau
country: Brazil
facility: CECIP - Centro de Estudos Clínicos do Interior Paulista
state: SP
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto Sirio Libanes de Ensino e Pesquisa
state: SP
city: Sao Paulo
country: Brazil
facility: Afip - Associacao Fundo de Incentivo A Psicofarmacologia
state: SP
Study officials:
affiliation: EMS
name: Roberto Amazonas, MD
role: STUDY_DIRECTOR
References: