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

September 21, 2005
April 26, 2012
June 2003
June 2005   (final data collection date for primary outcome measure)
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
Not Provided
Complete list of historical versions of study NCT00219310 on ClinicalTrials.gov Archive Site
  • 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.
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RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Genital Herpes (RGH)
Drug: Famciclovir
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2005
June 2005   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219310
CFAM810AUS07
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Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP