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Completed

NCT Number: NCT00219310

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

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.

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Key information

Conditions

Recurrent Genital Herpes (RGH) Communicable Diseases DNA Virus Infections Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famciclovir

Drug

Primary outcomes

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

Secondary outcomes

  1. Change in total score of the Recurrent Genital Herpes Quality of Life.

  2. Safety assessed by adverse events.

  3. Time to first recurrence of genital herpes.

  4. Number of genital herpes recurrences confirmed by PCR.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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