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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00477334
Other study ID # CFAM810A2310
Secondary ID
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


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
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