search
Back to results

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

Primary Purpose

Genital Herpes

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Famciclovir
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes focused on measuring Recurrent genital herpes, Black population

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence Clinical Research
  • Alia Clinical Research, INC
  • Dermatology Research Associates
  • The Conant Foundation Quest Diagnostics
  • Medical Research Centers of South Florida, Inc.
  • First Coast Primary Care Minority Physicians Research Alliance
  • AppleMed Research Inc.
  • International Research Associates, LLC
  • Segal Institute for Clinical Research Heathcare Clinical Data, Inc
  • Perimeter Institute for Clinical Research Inc. ("PICR")
  • Medical College of Georgia Hospital and Clinics
  • Soapstone Center for Clinical Research
  • Mount Vernon Clinical Research, LLC
  • Clinical Trials Management LLC
  • Tulane University Health Sciences Center
  • Omni Fertility and Laser Institute
  • International Research Center
  • Miray Medical Center
  • Pearl Medical Group, PLLC
  • Dr. Mohammed
  • Nevada Alliance Against Diabetes
  • Metrolina Internal Medicine Internal Medicine Research
  • Peters Medical Research
  • UNC Clinical Research
  • Hawthorne Medical Research, Inc.
  • Planned Parenthood of Arkansas and Eastern Oklahoma
  • The Clinical Trial Center, LLC
  • Magee-Womens Hospital of UPMC
  • Women's Care Center, PLC: Research Memphis Associates
  • Private Practice
  • R/D Clinical Research, Inc
  • Sun Research Institute
  • Millennium Clinical Trials, LLC
  • Josha Research
  • Prime Cure Medicentre
  • Drs. Essack and Mitha
  • Medunsa Clinical Research Unit (MeCRU)
  • Bertoni Mercy Clinic
  • Global Clinical Trials
  • Eastmed Clinical Trial Centre/Eastmed Medical Centre
  • Setshaba Research Centre
  • Drs. AE and QE Bhorat
  • Umkomaas Clinical Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Famciclovir 1000 mg; twice a day for one day.

Placebo; twice a day for one day.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
Kaplan-Meier estimation.
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.
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.
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.
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.
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)

Full Information

First Posted
May 22, 2007
Last Updated
March 24, 2011
Sponsor
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00477334
Brief Title
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
Recurrent genital herpes, Black population

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Famciclovir 1000 mg; twice a day for one day.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo; twice a day for one day.
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Other Intervention Name(s)
Famvir
Intervention Description
oral; two 500 mg tablets twice a day; single day treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral; two tablets twice a day; single day treatment
Primary Outcome Measure Information:
Title
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Description
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).
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
Time Frame
21 days
Title
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
Description
Kaplan-Meier estimation.
Time Frame
21 days
Title
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Description
Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.
Time Frame
72 hour after initiation of study medication up to 21 days
Title
Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period
Description
Number of participants with a second recurrence of genital herpes in the follow-up period.
Time Frame
6 months
Title
Time to Second Recurrence of Genital Herpes
Description
Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.
Time Frame
6 months
Title
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment
Description
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.
Time Frame
Baseline, Day 2
Title
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment
Description
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)
Time Frame
Baseline, Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalu Mohammed, Dr
Organizational Affiliation
Clayton Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Alia Clinical Research, INC
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
The Conant Foundation Quest Diagnostics
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Medical Research Centers of South Florida, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
First Coast Primary Care Minority Physicians Research Alliance
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32208
Country
United States
Facility Name
AppleMed Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Perimeter Institute for Clinical Research Inc. ("PICR")
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Medical College of Georgia Hospital and Clinics
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Trials Management LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Omni Fertility and Laser Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
International Research Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Pearl Medical Group, PLLC
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Dr. Mohammed
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Nevada Alliance Against Diabetes
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Metrolina Internal Medicine Internal Medicine Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
UNC Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Planned Parenthood of Arkansas and Eastern Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Women's Care Center, PLC: Research Memphis Associates
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Private Practice
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76110
Country
United States
Facility Name
R/D Clinical Research, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Millennium Clinical Trials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Josha Research
City
Bloemfontein
Country
South Africa
Facility Name
Prime Cure Medicentre
City
Durban
Country
South Africa
Facility Name
Drs. Essack and Mitha
City
Johannesburg
Country
South Africa
Facility Name
Medunsa Clinical Research Unit (MeCRU)
City
Medunsa
Country
South Africa
Facility Name
Bertoni Mercy Clinic
City
Mmakau Village GA Rankuwa
Country
South Africa
Facility Name
Global Clinical Trials
City
Port Elizabeth
Country
South Africa
Facility Name
Eastmed Clinical Trial Centre/Eastmed Medical Centre
City
Pretoria
Country
South Africa
Facility Name
Setshaba Research Centre
City
Shoshanguve
Country
South Africa
Facility Name
Drs. AE and QE Bhorat
City
Soweto
Country
South Africa
Facility Name
Umkomaas Clinical Research Site
City
Umkomaas
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
20070143
Citation
Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/webapp/etrials/DiseaseID58/Genital-Herpes-clinical-trials.go
Description
Click here for more information on this study

Learn more about this trial

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

We'll reach out to this number within 24 hrs