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Completed

NCT Number: NCT00306787

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

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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

Novartis Investigative Site, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years old
  • History of at least 4 recurrences of genital herpes in the preceding 12 months
  • Lesions located on the external genitalia or anogenital region
  • Willing to discontinue suppressive treatment
  • Documented positive herpes simplex virus (HSV)
  • General good health, and history of normal renal function

Exclusion criteria

  • Women of childbearing potential not using approved form of contraceptive
  • Pregnant or nursing women
  • History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
  • Known to be immunosuppressed
  • Known to have renal dysfunction
  • Receiving anti-herpes therapy
  • Known to have other genital tract disorders
  • Known to have condition which could interfere with drug absorption

Additional protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Famciclovir

Drug

Famciclovir 500 mg tablet

Other names: Famvir

Valacyclovir

Drug

Valacyclovir 500 mg capsule

Other names: Valtrex

Placebo matching famciclovir

Drug

Famciclovir placebo, matching in size, color and forms of famciclovir tablet.

Placebo matching valacyclovir

Drug

Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.

Primary outcomes

  1. Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions

    Time frame: 72 hours after initiation of study medication up to Day 20

    Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.

Secondary outcomes

  1. Percentage of Participants With Aborted Genital Herpes Lesions

    Time frame: 72 hours after initiation of study medication up to Day 20

    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.

  2. Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions

    Time frame: 72 hours after initiation of study medication up to Day 20

    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.

  3. Time to Resolution of Symptoms Associated With Recurrent Genital Herpes

    Time frame: 72 hours after initiation of study medication up to Day 20

    Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.

  4. Number of Patients With a Second Recurrence of Genital Herpes

    Time frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes

    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.

  5. Time to a Second Recurrence of Genital Herpes

    Time frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes

    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:

    • From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or
    • From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 24, 2006
Registry last updated
Jun 30, 2011

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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