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)

Sponsor

aRigen Pharmaceuticals, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00652184

Collaborator

(none)

300

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Mar 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Sep 1, 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
Other: 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

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. [Day 8]

Secondary Outcome Measures

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. [Day 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	ARYS-0701 Site 3	Beverly Hills	California	United States	90211
2	ARYS-0701 Site 6	Encino	California	United States	91436
3	ARYS-0701 Site 7	Vista	California	United States	92083
4	ARYS-0701 Site 8	Henderson	Nevada	United States	89014
5	ARYS-0701 Site 9	Las Vegas	Nevada	United States	89106
6	ARYS-0701 Site 10	New York	New York	United States	10003
7	ARYS-0701 Site 11	New York	New York	United States	10029
8	ARYS-0701 Site 4	New York	New York	United States	10032
9	ARYS-0701 Site 12	Raleigh	North Carolina	United States	27612
10	ARYS-0701 Site 1	Houston	Texas	United States	77058