Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
- Conditions
- Genital Herpes
- Interventions
- Registration Number
- NCT00306787
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1179
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Famciclovir Placebo matching valacyclovir Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. Valacyclovir Placebo matching famciclovir Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. Famciclovir Famciclovir Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. Valacyclovir Valacyclovir Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
- Primary Outcome Measures
Name Time Method Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions 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 Outcome Measures
Name Time Method Percentage of Participants With Aborted Genital Herpes Lesions 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 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 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 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 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.
Trial Locations
- Locations (52)
Providence Clinical Research
🇺🇸Burbank, California, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
UNC Clinical Research.
🇺🇸Raleigh, North Carolina, United States
Clayton Research Institute
🇺🇸St. Louis, Missouri, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Mount Vernon Clinical Research
🇺🇸Atlanta, Georgia, United States
Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Paddington Testing Co. Inc
🇺🇸Philadelphia, Pennsylvania, United States
S. Carolina Clinical Research Center
🇺🇸Columbia, South Carolina, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Indiana University Infectious Disease Research Group
🇺🇸Indianapolis, Indiana, United States
Center for Clinical Studies (TX Medical Center)
🇺🇸Houston, Texas, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Conant Research
🇺🇸San Francisco, California, United States
International Research Association LLC
🇺🇸Miami, Florida, United States
Lynne Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah-School of Medicine (Div. of Inf. Disease)
🇺🇸Salt Lake City, Utah, United States
University of Washington, Virology Research Clinic
🇺🇸Seattle, Washington, United States
Barbara Davis Center
🇺🇸Denver, Colorado, United States
Heartland Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
Salt Lake Women's Center/Physician's Research Options
🇺🇸Sandy, Utah, United States
Clinical Trials of Virginia, Inc.
🇺🇸Richmond, Virginia, United States
Renaissance Clinical Research and Hypertension Clinic
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Novartis Investigative Site
🇦🇺Darlinghurst, New South Wales, Australia
Quality of Life Medical & Research Center, LLC
🇺🇸Tucson, Arizona, United States
NEA Women's Clinic
🇺🇸Jonesboro, Arkansas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
The Woman's Clinic
🇺🇸Little Rock, Arkansas, United States
Sacramento Research Medical Group
🇺🇸Sacramento, California, United States
North California Research Corp.
🇺🇸Sacramento, California, United States
Cohen & Womack, P.C.
🇺🇸Lakewood, Colorado, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Orlando Clinical Research Ctr.
🇺🇸Orlando, Florida, United States
Avancia Research
🇺🇸Pembroke Pines, Florida, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Deaconess Billings Clinic Research Center
🇺🇸Billings, Montana, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Medisphere Medical Research Center, LLC.
🇺🇸Evansville, Indiana, United States
Common Wealth Biomedical Research
🇺🇸Madisonville, Kentucky, United States
SNBL Clinical Pharmacology Center
🇺🇸Baltimore, Maryland, United States
Future Care Studies
🇺🇸Springfield, Massachusetts, United States
Hawthorne Medical Research, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Providence Health Partners-Center for Clinical Research
🇺🇸Dayton, Ohio, United States
Research Inc.
🇺🇸Florence, South Carolina, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Simpsonville, South Carolina, United States
Benchmark Research
🇺🇸Austin, Texas, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
Novartis Investigational Site
🇩🇪Wolfsburg, Germany