Back to resultsA Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Primary Purpose
Genital Herpes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Famciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Genital Herpes focused on measuring Genital herpes, viral shedding, famciclovir, Symptomatic genital herpes, Asymptomatic genital herpes
Eligibility Criteria
Inclusion Criteria: Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes Exclusion Criteria: Pregnancy History of renal dysfunction Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
Sites / Locations
- University of Alabama at Birmingham
- Orlando Clinical Research Center
- IU Center for Clinical STD Research
- UNC Clinical Research - Raleigh
- Lynne Health Science Institute
- Westover Heights Clinic
- University of Washington - Virology Research Clinic
Outcomes
Primary Outcome Measures
Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
Secondary Outcome Measures
reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00129818
Brief Title
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Official Title
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
Genital herpes, viral shedding, famciclovir, Symptomatic genital herpes, Asymptomatic genital herpes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Primary Outcome Measure Information:
Title
Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Title
Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
Secondary Outcome Measure Information:
Title
reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
Title
quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
Title
time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
Title
oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
Title
reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes
Exclusion Criteria:
Pregnancy
History of renal dysfunction
Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
IU Center for Clinical STD Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
UNC Clinical Research - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Lynne Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Washington - Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
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