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

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ClinicalTrials.gov Identifier: NCT00477334
Recruitment Status : Completed
First Posted : May 23, 2007
Results First Posted : March 16, 2011
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Genital Herpes Drug: Famciclovir Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Famciclovir

Arm Intervention/treatment
Experimental: 1
Famciclovir 1000 mg; twice a day for one day.
Drug: Famciclovir
oral; two 500 mg tablets twice a day; single day treatment
Other Name: Famvir

Placebo Comparator: 2
Placebo; twice a day for one day.
Drug: Placebo
oral; two tablets twice a day; single day treatment




Primary Outcome Measures :
  1. Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 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 :
  1. Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period [ Time Frame: 21 days ]
  2. Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions [ Time Frame: 21 days ]
    Kaplan-Meier estimation.

  3. Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 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.

  4. Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period [ Time Frame: 6 months ]
    Number of participants with a second recurrence of genital herpes in the follow-up period.

  5. Time to Second Recurrence of Genital Herpes [ Time Frame: 6 months ]
    Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.

  6. The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment [ Time Frame: 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.

  7. The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment [ Time Frame: 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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477334


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Locations
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United States, California
Providence Clinical Research
Burbank, California, United States, 91505
Alia Clinical Research, INC
Huntington Park, California, United States, 90255
Dermatology Research Associates
Los Angeles, California, United States, 90045
The Conant Foundation Quest Diagnostics
San Francisco, California, United States, 94114
United States, Florida
Medical Research Centers of South Florida, Inc.
Hollywood, Florida, United States, 33021
First Coast Primary Care Minority Physicians Research Alliance
Jacksonville, Florida, United States, 32208
AppleMed Research Inc.
Miami, Florida, United States, 33155
International Research Associates, LLC
Miami, Florida, United States, 33156
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
North Miami, Florida, United States, 33161
United States, Georgia
Perimeter Institute for Clinical Research Inc. ("PICR")
Atlanta, Georgia, United States, 30338
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States, 30912
Soapstone Center for Clinical Research
Decatur, Georgia, United States, 30034
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
United States, Louisiana
Clinical Trials Management LLC
Covington, Louisiana, United States, 70433
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States, 71118
United States, Maryland
International Research Center
Towson, Maryland, United States, 21286
United States, Massachusetts
Miray Medical Center
Brockton, Massachusetts, United States, 02301
United States, Michigan
Pearl Medical Group, PLLC
Southfield, Michigan, United States, 48075
United States, Missouri
Dr. Mohammed
St. Louis, Missouri, United States, 63117
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, North Carolina
Metrolina Internal Medicine Internal Medicine Research
Charlotte, North Carolina, United States, 28204
Peters Medical Research
High Point, North Carolina, United States, 27262
UNC Clinical Research
Raleigh, North Carolina, United States, 27607
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Planned Parenthood of Arkansas and Eastern Oklahoma
Tulsa, Oklahoma, United States, 74105
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Women's Care Center, PLC: Research Memphis Associates
Memphis, Tennessee, United States, 38119
United States, Texas
Private Practice
Fort Worth, Texas, United States, 76110
R/D Clinical Research, Inc
Houston, Texas, United States, 77074
Sun Research Institute
San Antonio, Texas, United States, 78205
United States, Virginia
Millennium Clinical Trials, LLC
Arlington, Virginia, United States, 22203
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, South Africa
Sponsors and Collaborators
Novartis
Investigators
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Principal Investigator: Dalu Mohammed, Dr Clayton Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00477334     History of Changes
Other Study ID Numbers: CFAM810A2310
First Posted: May 23, 2007    Key Record Dates
Results First Posted: March 16, 2011
Last Update Posted: March 28, 2011
Last Verified: March 2011
Keywords provided by Novartis:
Recurrent genital herpes
Black population
Additional relevant MeSH terms:
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Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Famciclovir
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action