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

Phase 4CompletedNCT00219310

Novartis

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Recurrent Genital Herpes (RGH)

Interventions

FamciclovirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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