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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Adult

Brief Summary: 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).

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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:

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


Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: March 22, 2006
Date Started: March 2006
Date Completion:
Last Updated: June 28, 2011
Last Verified: June 2011