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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,179
Famciclovir 500 mg tablet
Valacyclovir 500 mg capsule
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
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.
Time frame: 72 hours after initiation of study medication up to Day 20
Percentage of Participants With Aborted Genital Herpes Lesions
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.
Time frame: 72 hours after initiation of study medication up to Day 20
Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions
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 frame: 72 hours after initiation of study medication up to Day 20
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
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.
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Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Novartis Investigative Site
Chandler, Arizona, United States
Women's Health Research
Phoenix, Arizona, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
NEA Women's Clinic
Jonesboro, Arkansas, United States
The Woman's Clinic
Little Rock, Arkansas, United States
Providence Clinical Research
Burbank, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Sacramento Research Medical Group
Sacramento, California, United States
...and 56 more locations
Time frame: 72 hours after initiation of study medication up to Day 20
Number of Patients With a Second 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 frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes
Time to a Second 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.
Time frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes