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)
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ClinicalTrials.gov Identifier: NCT00652184 |
Recruitment Status : Unknown
Verified October 2008 by aRigen Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 3, 2008
Last Update Posted : October 7, 2008
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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 |
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 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 |

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:
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:
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:
Drug: valaciclovir active valaciclovir |
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652184
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 |
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 Key Record Dates |
Last Update Posted: | October 7, 2008 |
Last Verified: | October 2008 |
antiviral herpes zoster postherpetic neuralgia varicella zoster virus shingles |
Herpes Zoster Neuralgia Neuralgia, Postherpetic Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations |
Varicella Zoster Virus Infection Herpesviridae Infections DNA Virus Infections Virus Diseases Valacyclovir Sorivudine Antiviral Agents Anti-Infective Agents |