Back to resultsRELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
Primary Purpose
Recurrent Genital Herpes (RGH)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Famciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Genital Herpes (RGH) focused on measuring Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
Eligibility 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.
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00219310
Brief Title
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Genital Herpes (RGH)
Keywords
Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Famciclovir
Primary Outcome Measure Information:
Title
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
Secondary Outcome Measure Information:
Title
Change in total score of the Recurrent Genital Herpes Quality of Life.
Title
Safety assessed by adverse events.
Title
Time to first recurrence of genital herpes.
Title
Number of genital herpes recurrences confirmed by PCR.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18621575
Citation
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. doi: 10.1016/j.jcv.2008.06.004. Epub 2008 Jul 14. Erratum In: J Clin Virol. 2009 Feb;44(2):183.
Results Reference
derived
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RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
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