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NCT Number: NCT01281007

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

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.

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Key information

Conditions

Genital Herpes Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda, Porto Alegre, Rio Grande do Sul, Brazil

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famciclovir

Drug

Famciclovir 125 mg every 12 hours for 5 days

Aciclovir

Drug

Aciclovir 200 mg every 4 hours fo 5 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2011
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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