Study to Compare Efficacy of Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir and Combination ARYS-01 Cream 3%/Oral Valaciclovir for Treatment of Herpes Zoster (Shingles)

• ClinicalTrials.gov Identifier: NCT00652184
• Recruitment Status: Unknown
• First Posted: April 3, 2008
• Last Update Posted: October 7, 2008
• Sponsor: aRigen Pharmaceuticals, Inc.
• Information provided by: aRigen Pharmaceuticals, Inc.

Study Description

Brief Summary:

A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.

Condition or disease	Intervention/treatment	Phase
Herpes Zoster; Postherpetic Neuralgia	Drug: ARYS-01 (sorivudine) cream 3% or placebo cream; Drug: placebo; Drug: valaciclovir	Phase 2

Detailed Description:

More than 95% of people are infected with varicella Zoster virus (VZV) at one time of life or another. Primary VZV infection manifests as varicella (chicken pox). The virus then establishes a latent infection of the sensory ganglia from which it may reactivate years later to produce the clinical syndrome of Herpes Zoster (shingles). The initial cutaneous VZV lesions are pruritic, erythematous macules; and the lesions progress through maculopapular stage to vesicular, ulceration and crusting phases. The crusting phase signals the beginning of the healing process, and begins with clouding of the vesicular fluid, within about 24 to 48 h after the appearance of each lesion. This is a Phase 2 study to assess: 1) the overall benefit of ARYS-01 (sorivudine) cream 3% vs. Placebo cream (with immediate or delayed use of Valaciclovir therapy) on Herpes Zoster rash healing rates and postherpetic neuralgia (PHN), 2) the efficacy of ARYS-01 cream 3% vs. Placebo cream, prior to initiation of Valaciclovir, to build evidence for monotherapy treatment benefit of ARYS-01 cream on the initial onset of Herpes Zoster symptoms, 3) the efficacy of ARYS-01 cream 3% vs. Placebo cream, with immediate or delayed initiation of Valaciclovir, for synergetic effects on the initial onset of Herpes Zoster symptoms.

The primary efficacy endpoint is the effect of ARYS-01 cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8. Secondary endpoints include time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 2/3 Multi-Center, Double-Blind, Controlled Trial Comparing Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir, and Combination Topical ARYS-01 Cream /Oral Valaciclovir for Treatment of Herpes Zoster in Immunocompetent Patients 18 Years of Age or Older
• Study Start Date: March 2008
• Estimated Primary Completion Date: June 2009
• Estimated Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 1; Placebo cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10	Drug: placebo; placebo cream and placebo valaciclovir; Drug: valaciclovir; active valaciclovir
Active Comparator: 2; Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10	Drug: ARYS-01 (sorivudine) cream 3% or placebo cream; sorivudine cream 3% or placebo cream twice daily for 10 days; Other Names: ARYS-01 cream 3%; sorivudine cream 3%; topical sorivudine 3%; Drug: placebo; placebo cream and placebo valaciclovir; Drug: valaciclovir; active valaciclovir
Experimental: 3; Active cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10	Drug: ARYS-01 (sorivudine) cream 3% or placebo cream; sorivudine cream 3% or placebo cream twice daily for 10 days; Other Names: ARYS-01 cream 3%; sorivudine cream 3%; topical sorivudine 3%; Drug: placebo; placebo cream and placebo valaciclovir; Drug: valaciclovir; active valaciclovir
4; Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10	Drug: ARYS-01 (sorivudine) cream 3% or placebo cream; sorivudine cream 3% or placebo cream twice daily for 10 days; Other Names: ARYS-01 cream 3%; sorivudine cream 3%; topical sorivudine 3%; Drug: valaciclovir; active valaciclovir

Outcome Measures

Primary Outcome Measures :

1. The effect of ARYS-01 (sorivudine) cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8. [ Time Frame: Day 8 ]

Secondary Outcome Measures :

1. The time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination. [ Time Frame: Day 4 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• at least 18 years of age
• diagnosed with herpes zoster
• confirmed for VZV with lesion swab at screening and subsequent PCR test.
• contraception for women of child-bearing potential
• be able to communicate with investigator and compliant

Exclusion Criteria:

• cytotoxic or immunosuppressive drugs within 3 mos, 5-FU or its pro-drugs, tricyclic antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory agents for viral infection
• herpes zoster ophthalmicus
• female patients who are pregnant and/or nursing or planning a pregnancy
• congenital, acquired or corticosteroid-induced immunodeficiency, including malignancy
• renal insufficiency or creatinine level >2mg/dL
• clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab
• history of intolerance or hypersensitivity to the cream components
• current significant skin disease within affected dermatome
• history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV
• current participation in another clinical drug research study

Contacts and Locations

Locations

United States, California

ARYS-0701 Site 3

Beverly Hills, California, United States, 90211

ARYS-0701 Site 6

Encino, California, United States, 91436

ARYS-0701 Site 7

Vista, California, United States, 92083

United States, Nevada

ARYS-0701 Site 8

Henderson, Nevada, United States, 89014

ARYS-0701 Site 9

Las Vegas, Nevada, United States, 89106

United States, New York

ARYS-0701 Site 10

New York, New York, United States, 10003

ARYS-0701 Site 11

New York, New York, United States, 10029

ARYS-0701 Site 4

New York, New York, United States, 10032

United States, North Carolina

ARYS-0701 Site 12

Raleigh, North Carolina, United States, 27612

United States, Texas

ARYS-0701 Site 1

Houston, Texas, United States, 77058

Sponsors and Collaborators

aRigen Pharmaceuticals, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Satyaprakash AK, Tremaine AM, Stelter AA, Creed R, Ravanfar P, Mendoza N, Mehta SK, Rady PL, Pierson DL, Tyring SK. Viremia in acute herpes zoster. J Infect Dis. 2009 Jul 1;200(1):26-32. doi: 10.1086/599381.

• Responsible Party: President and Chief Executive Officer, aRigen Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00652184
• Other Study ID Numbers: ARYS-0701
• First Posted: April 3, 2008
• Last Update Posted: October 7, 2008
• Last Verified: October 2008

Keywords provided by aRigen Pharmaceuticals, Inc.:

antiviral; herpes zoster; postherpetic neuralgia; varicella zoster virus; shingles

Additional relevant MeSH terms:

Herpes Zoster; Neuralgia; Neuralgia, Postherpetic; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Valacyclovir; Sorivudine; Antiviral Agents; Anti-Infective Agents