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

Primary Purpose

Genital Herpes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Famciclovir
Valacyclovir
Placebo matching famciclovir
Placebo matching valacyclovir
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes focused on measuring Herpes simplex, genital herpes, famciclovir, valacyclovir, Recurrent genital herpes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Novartis Investigative Site
  • Women's Health Research
  • Quality of Life Medical & Research Center, LLC
  • Burke Pharmaceutical Research
  • NEA Women's Clinic
  • The Woman's Clinic
  • Providence Clinical Research
  • Dermatology Research Associates
  • Sacramento Research Medical Group
  • North California Research Corp.
  • Medical Center for Clinical Research
  • Conant Research
  • Barbara Davis Center
  • Cohen & Womack, P.C.
  • Visions Clinical Research
  • Women's Medical Research Group, LLC
  • International Research Association LLC
  • Orlando Clinical Research Ctr.
  • Avancia Research
  • University Clinical Research, Inc.
  • Palm Beach Research Center
  • Mount Vernon Clinical Research
  • Medisphere Medical Research Center, LLC.
  • Indiana University Infectious Disease Research Group
  • Heartland Research Associates, LLC
  • Common Wealth Biomedical Research
  • SNBL Clinical Pharmacology Center
  • Future Care Studies
  • Clayton Research Institute
  • Deaconess Billings Clinic Research Center
  • Heartland Clinical Research, Inc.
  • UNC Clinical Research.
  • Hawthorne Medical Research, Inc.
  • Providence Health Partners-Center for Clinical Research
  • Lynne Health Science Institute
  • Westover Heights Clinic
  • Paddington Testing Co. Inc
  • Magee Womens Hospital
  • S. Carolina Clinical Research Center
  • Research Inc.
  • Palmetto Clinical Trial Services, LLC
  • Benchmark Research
  • Renaissance Clinical Research and Hypertension Clinic
  • Center for Clinical Studies (TX Medical Center)
  • Center for Clinical Studies
  • University of Utah-School of Medicine (Div. of Inf. Disease)
  • Salt Lake Women's Center/Physician's Research Options
  • Clinical Trials of Virginia, Inc.
  • University of Washington, Virology Research Clinic
  • Liberty Research Center
  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Famciclovir

Valacyclovir

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 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.
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 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: 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.

Full Information

First Posted
March 22, 2006
Last Updated
June 28, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00306787
Brief Title
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
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 Adults With Recurrent Genital Herpes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
Herpes simplex, genital herpes, famciclovir, valacyclovir, Recurrent genital herpes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Famciclovir
Arm Type
Experimental
Arm Description
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.
Arm Title
Valacyclovir
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Other Intervention Name(s)
Famvir
Intervention Description
Famciclovir 500 mg tablet
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Other Intervention Name(s)
Valtrex
Intervention Description
Valacyclovir 500 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo matching famciclovir
Intervention Description
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo matching valacyclovir
Intervention Description
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Primary Outcome Measure Information:
Title
Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With Aborted Genital Herpes Lesions
Description
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
Title
Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions
Description
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
Title
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Description
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.
Time Frame
72 hours after initiation of study medication up to Day 20
Title
Number of Patients With a Second Recurrence of Genital Herpes
Description
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
Title
Time to a Second Recurrence of Genital Herpes
Description
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.
Time Frame
Up to 6 months after investigator assessed healing of first recurrence of genital herpes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Novartis Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
NEA Women's Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
The Woman's Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Sacramento Research Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
North California Research Corp.
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Conant Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Barbara Davis Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Cohen & Womack, P.C.
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
International Research Association LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Orlando Clinical Research Ctr.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Avancia Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Medisphere Medical Research Center, LLC.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Indiana University Infectious Disease Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Common Wealth Biomedical Research
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
SNBL Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Clayton Research Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Deaconess Billings Clinic Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Heartland Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
UNC Clinical Research.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Providence Health Partners-Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Lynne Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Paddington Testing Co. Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
S. Carolina Clinical Research Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Research Inc.
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Renaissance Clinical Research and Hypertension Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Center for Clinical Studies (TX Medical Center)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
University of Utah-School of Medicine (Div. of Inf. Disease)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Salt Lake Women's Center/Physician's Research Options
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Clinical Trials of Virginia, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
University of Washington, Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Liberty Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Novartis Investigative Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Novartis Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B6
Country
Canada
Facility Name
Novartis Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Novartis Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0W3
Country
Canada
Facility Name
Novartis Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
Novartis Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 0G8
Country
Canada
Facility Name
Novartis Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7X 3S5
Country
Canada
Facility Name
Novartis Investigational Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Novartis Investigational Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3H IV4
Country
Canada
Facility Name
Novartis Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Novartis Investigational Site
City
Augsburg
ZIP/Postal Code
D-86179
Country
Germany
Facility Name
Novartis Investigational Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigational Site
City
Rostock
ZIP/Postal Code
D-18055
Country
Germany
Facility Name
Novartis Investigational Site
City
Wolfsburg
ZIP/Postal Code
D-38440
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19192993
Citation
Bodsworth N, Fife K, Koltun W, Tyring S, Abudalu M, Prichard M, Hamed K. Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Curr Med Res Opin. 2009 Feb;25(2):483-7. doi: 10.1185/03007990802664678.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=520
Description
eRecruitment

Learn more about this trial

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

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