A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
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ClinicalTrials.gov Identifier: NCT00129818 |
Recruitment Status
:
Completed
First Posted
: August 12, 2005
Last Update Posted
: April 27, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Genital Herpes | Drug: Famciclovir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129818
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
Orlando Clinical Research Center | |
Orlando, Florida, United States, 32809 | |
United States, Indiana | |
IU Center for Clinical STD Research | |
Indianapolis, Indiana, United States, 46202 | |
United States, North Carolina | |
UNC Clinical Research - Raleigh | |
Raleigh, North Carolina, United States, 27607 | |
United States, Oklahoma | |
Lynne Health Science Institute | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Oregon | |
Westover Heights Clinic | |
Portland, Oregon, United States, 97210 | |
United States, Washington | |
University of Washington - Virology Research Clinic | |
Seattle, Washington, United States, 98122 |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00129818 History of Changes |
Other Study ID Numbers: |
CFAM810A2404 |
First Posted: | August 12, 2005 Key Record Dates |
Last Update Posted: | April 27, 2012 |
Last Verified: | April 2012 |
Keywords provided by Novartis:
Genital herpes viral shedding famciclovir Symptomatic genital herpes Asymptomatic genital herpes |
Additional relevant MeSH terms:
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male |
Genital Diseases, Female Famciclovir 2-Aminopurine Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |