Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

Genital Herpes Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477334
• Other study ID #: CFAM810A2310
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2007
• Last updated: March 24, 2011
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Black men or women 18 years or older

• History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy

• Documented herpes simplex virus type 2 (HSV-2) seropositivity

• Willingness to discontinue suppressive therapy during study, if applicable

• Willingness and ability to comply with the study protocol

Exclusion Criteria:

• Pregnant or breastfeeding women

• Women of childbearing potential not using accepted methods of contraception

• Hypersensitivity to famciclovir or drugs with similar chemical structures

• Renal dysfunction

• Known or suspected to have decompensated liver disease

• Known to have gastrointestinal malabsorption

• Known to be immunocompromised

• Known to be hypersensitive to ingredients in study medication

• Other 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

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• Famciclovir
oral; two 500 mg tablets twice a day; single day treatment
• Placebo
oral; two tablets twice a day; single day treatment

Locations

Country	Name	City	State
South Africa	Josha Research	Bloemfontein
South Africa	Prime Cure Medicentre	Durban
South Africa	Drs. Essack and Mitha	Johannesburg
South Africa	Medunsa Clinical Research Unit (MeCRU)	Medunsa
South Africa	Bertoni Mercy Clinic	Mmakau Village GA Rankuwa
South Africa	Global Clinical Trials	Port Elizabeth
South Africa	Eastmed Clinical Trial Centre/Eastmed Medical Centre	Pretoria
South Africa	Setshaba Research Centre	Shoshanguve
South Africa	Drs. AE and QE Bhorat	Soweto
South Africa	Umkomaas Clinical Research Site	Umkomaas
United States	Millennium Clinical Trials, LLC	Arlington	Virginia
United States	Perimeter Institute for Clinical Research Inc. ("PICR")	Atlanta	Georgia
United States	Medical College of Georgia Hospital and Clinics	Augusta	Georgia
United States	Miray Medical Center	Brockton	Massachusetts
United States	Providence Clinical Research	Burbank	California
United States	Metrolina Internal Medicine Internal Medicine Research	Charlotte	North Carolina
United States	Clinical Trials Management LLC	Covington	Louisiana
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Private Practice	Fort Worth	Texas
United States	Peters Medical Research	High Point	North Carolina
United States	Medical Research Centers of South Florida, Inc.	Hollywood	Florida
United States	R/D Clinical Research, Inc	Houston	Texas
United States	Alia Clinical Research, INC	Huntington Park	California
United States	First Coast Primary Care Minority Physicians Research Alliance	Jacksonville	Florida
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Nevada Alliance Against Diabetes	Las Vegas	Nevada
United States	Dermatology Research Associates	Los Angeles	California
United States	Women's Care Center, PLC: Research Memphis Associates	Memphis	Tennessee
United States	AppleMed Research Inc.	Miami	Florida
United States	International Research Associates, LLC	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Segal Institute for Clinical Research Heathcare Clinical Data, Inc	North Miami	Florida
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	UNC Clinical Research	Raleigh	North Carolina
United States	Sun Research Institute	San Antonio	Texas
United States	The Conant Foundation Quest Diagnostics	San Francisco	California
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Omni Fertility and Laser Institute	Shreveport	Louisiana
United States	Pearl Medical Group, PLLC	Southfield	Michigan
United States	Dr. Mohammed	St. Louis	Missouri
United States	International Research Center	Towson	Maryland
United States	Planned Parenthood of Arkansas and Eastern Oklahoma	Tulsa	Oklahoma
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  South Africa, 

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, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).	21 days	No
Secondary	Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period		21 days	No
Secondary	Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions	Kaplan-Meier estimation.	21 days	No
Secondary	Time to Resolution of Symptoms Associated With Recurrent Genital Herpes	Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.	72 hour after initiation of study medication up to 21 days	No
Secondary	Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period	Number of participants with a second recurrence of genital herpes in the follow-up period.	6 months	No
Secondary	Time to Second Recurrence of Genital Herpes	Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.	6 months	No
Secondary	The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment	The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.	Baseline, Day 2	No
Secondary	The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment	The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.; SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)	Baseline, Day 2	No