A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Genital Herpes Clinical Trial

Official title:

A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129818
• Other study ID #: CFAM810A2404
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2005
• Last updated: April 26, 2012
• Start date: July 2004
• Est. completion date: October 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• Famciclovir

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	IU Center for Clinical STD Research	Indianapolis	Indiana
United States	Lynne Health Science Institute	Oklahoma City	Oklahoma
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Westover Heights Clinic	Portland	Oregon
United States	UNC Clinical Research - Raleigh	Raleigh	North Carolina
United States	University of Washington - Virology Research Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Primary	Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
Secondary	reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
Secondary	quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
Secondary	time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
Secondary	oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
Secondary	reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions