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

NCT ID: NCT00219310

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Genital Herpes (RGH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Famciclovir

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.jcv.2008.06.004. Epub 2008 Jul 14.

Reference Type DERIVED
PMID: 18621575 (View on PubMed)

Other Identifiers

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CFAM810AUS07

Identifier Type: -

Identifier Source: org_study_id

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