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

Recurrent Genital Herpes (RGH) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219310
• Other study ID #: CFAM810AUS07
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: April 26, 2012
• Start date: June 2003
• Est. completion date: June 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

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.

Recruitment information / eligibility

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

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Genitalis
• Recurrent Genital Herpes (RGH)

Intervention

Drug:
• Famciclovir

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
Secondary	Change in total score of the Recurrent Genital Herpes Quality of Life.
Secondary	Safety assessed by adverse events.
Secondary	Time to first recurrence of genital herpes.
Secondary	Number of genital herpes recurrences confirmed by PCR.