Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00306787
Other study ID # CFAM810A2308
Secondary ID
Status Completed
Phase Phase 3
First received March 22, 2006
Last updated June 28, 2011
Start date March 2006
Est. completion date February 2008

Study information

Verified date June 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1179
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Famciclovir
Famciclovir 500 mg tablet
Valacyclovir
Valacyclovir 500 mg capsule
Placebo matching famciclovir
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Placebo matching valacyclovir
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.

Locations

Country Name City State
Australia Novartis Investigative Site Darlinghurst New South Wales
Canada Novartis Investigational Site Edmonton Alberta
Canada Novartis Investigational Site Laval Quebec
Canada Novartis Investigational Site Markham Ontario
Canada Novartis Investigational Site Montréal Quebec
Canada Novartis Investigational Site Montréal Quebec
Canada Novartis Investigational Site Ottawa Ontario
Canada Novartis Investigational Site Sainte-Foy Quebec
Canada Novartis Investigational Site Vancouver British Columbia
Canada Novartis Investigational Site Winnipeg Manitoba
Germany Novartis Investigational Site Augsburg
Germany Novartis Investigational Site Berlin
Germany Novartis Investigational Site Freiburg
Germany Novartis Investigational Site Rostock
Germany Novartis Investigational Site Wolfsburg
United States Mount Vernon Clinical Research Atlanta Georgia
United States Benchmark Research Austin Texas
United States SNBL Clinical Pharmacology Center Baltimore Maryland
United States Deaconess Billings Clinic Research Center Billings Montana
United States University of Alabama at Birmingham Birmingham Alabama
United States Visions Clinical Research Boynton Beach Florida
United States Providence Clinical Research Burbank California
United States Novartis Investigative Site Chandler Arizona
United States Women's Medical Research Group, LLC Clearwater Florida
United States S. Carolina Clinical Research Center Columbia South Carolina
United States Renaissance Clinical Research and Hypertension Clinic Dallas Texas
United States Providence Health Partners-Center for Clinical Research Dayton Ohio
United States Barbara Davis Center Denver Colorado
United States Medisphere Medical Research Center, LLC. Evansville Indiana
United States Research Inc. Florence South Carolina
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Center for Clinical Studies Houston Texas
United States Center for Clinical Studies (TX Medical Center) Houston Texas
United States Indiana University Infectious Disease Research Group Indianapolis Indiana
United States NEA Women's Clinic Jonesboro Arkansas
United States Cohen & Womack, P.C. Lakewood Colorado
United States The Woman's Clinic Little Rock Arkansas
United States Dermatology Research Associates Los Angeles California
United States Common Wealth Biomedical Research Madisonville Kentucky
United States International Research Association LLC Miami Florida
United States Lynne Health Science Institute Oklahoma City Oklahoma
United States Heartland Clinical Research, Inc. Omaha Nebraska
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 Paddington Testing Co. Inc Philadelphia Pennsylvania
United States Women's Health Research Phoenix Arizona
United States Magee Womens Hospital Pittsburgh Pennsylvania
United States Westover Heights Clinic Portland Oregon
United States UNC Clinical Research. Raleigh North Carolina
United States Clinical Trials of Virginia, Inc. Richmond Virginia
United States North California Research Corp. Sacramento California
United States Sacramento Research Medical Group Sacramento California
United States University of Utah-School of Medicine (Div. of Inf. Disease) Salt Lake City Utah
United States Medical Center for Clinical Research San Diego California
United States Conant Research San Francisco California
United States Salt Lake Women's Center/Physician's Research Options Sandy Utah
United States University of Washington, Virology Research Clinic Seattle Washington
United States Palmetto Clinical Trial Services, LLC Simpsonville South Carolina
United States Future Care Studies Springfield Massachusetts
United States Clayton Research Institute St. Louis Missouri
United States Liberty Research Center Tacoma Washington
United States Quality of Life Medical & Research Center, LLC Tucson Arizona
United States Palm Beach Research Center West Palm Beach Florida
United States Heartland Research Associates, LLC Wichita Kansas
United States Hawthorne Medical Research, Inc. Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 72 hours after initiation of study medication up to Day 20 No
Secondary 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. 72 hours after initiation of study medication up to Day 20 No
Secondary 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. 72 hours after initiation of study medication up to Day 20 No
Secondary 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. 72 hours after initiation of study medication up to Day 20 No
Secondary 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. Up to 6 months after investigator assessed healing of first recurrence of genital herpes No
Secondary 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.
Up to 6 months after investigator assessed healing of first recurrence of genital herpes No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06033261 - A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes Phase 1/Phase 2
Completed NCT00362297 - Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 Phase 4
Completed NCT01132729 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions N/A
Completed NCT01132716 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions N/A
Completed NCT03831165 - Melatonin Effects on Genital Herpes in Brazilian Women Phase 4
Terminated NCT01658826 - Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes Phase 2
Completed NCT00262106 - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection Phase 3
Completed NCT01346475 - Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 Phase 4
Completed NCT01390805 - Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis) N/A
Terminated NCT03146403 - Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection Phase 2
Completed NCT03080961 - The VIBLOK SAfety and perFormancE Trial N/A
Completed NCT00231049 - Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Phase 1
Completed NCT00495573 - HSV-2 Shedding Resolution After Acyclovir Treatment N/A
Completed NCT00477334 - Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients Phase 4
Not yet recruiting NCT03595995 - A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 Phase 2
Completed NCT01281007 - Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes Phase 3
Completed NCT01112956 - Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2 N/A
Completed NCT00129818 - A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding Phase 4
Completed NCT00808405 - GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women N/A
Terminated NCT00495716 - Effect of HSV-2 Suppressive Therapy on Sexual Behavior Phase 4