RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219310

Purpose

This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.

Condition	Intervention	Phase
Recurrent Genital Herpes (RGH)	Drug: Famciclovir	Phase IV

Drug Information available for: Famciclovir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction

Further study details as provided by Novartis:

Primary Outcome Measures:

Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.

Secondary Outcome Measures:

Change in total score of the Recurrent Genital Herpes Quality of Life.
Safety assessed by adverse events.
Time to first recurrence of genital herpes.
Number of genital herpes recurrences confirmed by PCR.

Study Start Date:

June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

• Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.
- Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR).
- Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding.
- Current, history or suspicion of liver disease or kidney disease.
- HIV infected (as confirmed by positive HIV serology).

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219310

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Publications indexed to this study:

Bartlett BL, Tyring SK, Fife K, Gnann JW Jr, Hadala JT, Kianifard F, Berber E. Famciclovir treatment options for patients with frequent outbreaks of recurrent genital herpes: the RELIEF trial. J Clin Virol. 2008 Oct;43(2):190-5. Epub 2008 Jul 14.

Study ID Numbers:	CFAM810AUS07
Study First Received:	September 21, 2005
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00219310
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).

Study placed in the following topic categories:

Genital Diseases, Female
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Famciclovir
Herpes Genitalis

Sexually Transmitted Diseases
Quality of Life
DNA Virus Infections
Genital Diseases, Male
Recurrence
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Disease Attributes
Pathologic Processes

Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009