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

March 24, 2011 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

463

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Famvir
PLACEBO_COMPARATOR: 2
Placebo; twice a day for one day.
Drug: Placebo
oral; two tablets twice a day; single day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
Time Frame: 21 days
21 days
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
Time Frame: 21 days
Kaplan-Meier estimation.
21 days
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.
72 hour after initiation of study medication up to 21 days
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.
6 months
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 months
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.
Baseline, Day 2
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)
Baseline, Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Principal Investigator: Dalu Mohammed, Dr, Clayton Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (ESTIMATE)

May 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2011

Last Update Submitted That Met QC Criteria

March 24, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFAM810A2310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Genital Herpes

Clinical Trials on Famciclovir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe