NCT00129818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

August 11, 2005

Last Update Submit

April 26, 2012

Conditions

Genital Herpes

Keywords

Genital herpesviral sheddingfamciclovirSymptomatic genital herpesAsymptomatic genital herpes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Interventions

FamciclovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

IU Center for Clinical STD Research

Indianapolis, Indiana, 46202, United States

Location

UNC Clinical Research - Raleigh

Raleigh, North Carolina, 27607, United States

Location

Lynne Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

University of Washington - Virology Research Clinic

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

July 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(7)