Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
- Registration Number
- NCT00477334
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Famciclovir Famciclovir 1000 mg; twice a day for one day. 2 Placebo Placebo; twice a day for one day.
- Primary Outcome Measures
Name Time Method Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions 21 days 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).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period 21 days Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions 21 days Kaplan-Meier estimation.
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes 72 hour after initiation of study medication up to 21 days Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.
Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period 6 months Number of participants with a second recurrence of genital herpes in the follow-up period.
Time to Second Recurrence of Genital Herpes 6 months Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment Baseline, Day 2 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.
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment Baseline, Day 2 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)
Trial Locations
- Locations (43)
Perimeter Institute for Clinical Research Inc. ("PICR")
🇺🇸Atlanta, Georgia, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
The Conant Foundation Quest Diagnostics
🇺🇸San Francisco, California, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Nevada Alliance Against Diabetes
🇺🇸Las Vegas, Nevada, United States
R/D Clinical Research, Inc
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Medical Research Centers of South Florida, Inc.
🇺🇸Hollywood, Florida, United States
Medical College of Georgia Hospital and Clinics
🇺🇸Augusta, Georgia, United States
Metrolina Internal Medicine Internal Medicine Research
🇺🇸Charlotte, North Carolina, United States
Medunsa Clinical Research Unit (MeCRU)
🇿🇦Medunsa, South Africa
Providence Clinical Research
🇺🇸Burbank, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
AppleMed Research Inc.
🇺🇸Miami, Florida, United States
Alia Clinical Research, INC
🇺🇸Huntington Park, California, United States
Global Clinical Trials
🇿🇦Port Elizabeth, South Africa
Soapstone Center for Clinical Research
🇺🇸Decatur, Georgia, United States
Omni Fertility and Laser Institute
🇺🇸Shreveport, Louisiana, United States
Private Practice
🇺🇸Fort Worth, Texas, United States
Drs. AE and QE Bhorat
🇿🇦Soweto, South Africa
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Bertoni Mercy Clinic
🇿🇦Mmakau Village GA Rankuwa, South Africa
Setshaba Research Centre
🇿🇦Shoshanguve, South Africa
Umkomaas Clinical Research Site
🇿🇦Umkomaas, South Africa
Women's Care Center, PLC: Research Memphis Associates
🇺🇸Memphis, Tennessee, United States
Josha Research
🇿🇦Bloemfontein, South Africa
Prime Cure Medicentre
🇿🇦Durban, South Africa
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Planned Parenthood of Arkansas and Eastern Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Eastmed Clinical Trial Centre/Eastmed Medical Centre
🇿🇦Pretoria, South Africa
Clinical Trials Management LLC
🇺🇸Covington, Louisiana, United States
Drs. Essack and Mitha
🇿🇦Johannesburg, South Africa
First Coast Primary Care Minority Physicians Research Alliance
🇺🇸Jacksonville, Florida, United States
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
🇺🇸North Miami, Florida, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Dr. Mohammed
🇺🇸St. Louis, Missouri, United States
UNC Clinical Research
🇺🇸Raleigh, North Carolina, United States
Miray Medical Center
🇺🇸Brockton, Massachusetts, United States
Pearl Medical Group, PLLC
🇺🇸Southfield, Michigan, United States
International Research Center
🇺🇸Towson, Maryland, United States
Millennium Clinical Trials, LLC
🇺🇸Arlington, Virginia, United States
Hawthorne Medical Research, Inc.
🇺🇸Winston-Salem, North Carolina, United States