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)

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Herpes Zoster, Postherpetic Neuralgia

In brief

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

Key facts

Study ID

NCT00652184

Run by

aRigen Pharmaceuticals, Inc.

People needed

300

Starts

2008-03-01

Expected to finish

2009-09-01

Last updated by the study team

2008-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ARYS-0701 Site 3 — Beverly Hills, California, United States
• ARYS-0701 Site 6 — Encino, California, United States
• ARYS-0701 Site 7 — Vista, California, United States
• ARYS-0701 Site 8 — Henderson, Nevada, United States
• ARYS-0701 Site 9 — Las Vegas, Nevada, United States
• ARYS-0701 Site 10 — New York, New York, United States
• ARYS-0701 Site 11 — New York, New York, United States
• ARYS-0701 Site 4 — New York, New York, United States
• ARYS-0701 Site 12 — Raleigh, North Carolina, United States
• ARYS-0701 Site 1 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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