GENITAL HERPES | Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
GENITAL HERPES research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:FamciclovirFamciclovir 125 mg every 12 hours for 5 days
Drug:AciclovirAciclovir 200 mg every 4 hours fo 5 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Famciclovir 125 mg1 tablet every 12 hours for 5 days
Aciclovir 200 mg1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Start Date: July 2012
Completed Date: March 2015
Phase: Phase 3
Primary Outcome: Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Secondary Outcome: Safety Will be Evaluated by the Adverse Events Occurence
Study sponsors, principal investigator, and references
Principal Investigator: Roberto Amazonas, MD
Lead Sponsor: EMS