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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219310
First received: September 21, 2005
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes
Drug Information available for: Famciclovir
U.S. FDA Resources

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
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  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 Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00219310     History of Changes
Other Study ID Numbers: CFAM810AUS07
Study First Received: September 21, 2005
Last Updated: April 26, 2012
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).

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
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013