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

Novartis

Status and phase: Completed; Phase 4

Conditions: Recurrent Genital Herpes (RGH)

Treatments: Drug: Famciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219310

CFAM810AUS07

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)