Clinical trial NCT00652184: 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)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Herpes Zoster
Postherpetic Neuralgia
Keywords: antiviral
herpes zoster
postherpetic neuralgia
varicella zoster virus
shingles
Lead sponsor: aRigen Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Day 8
Secondary outcomes:
measure: 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.
timeFrame: Day 4
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: ARYS-0701 Site 3
state: California
city: Encino
country: United States
facility: ARYS-0701 Site 6
state: California
city: Vista
country: United States
facility: ARYS-0701 Site 7
state: California
city: Henderson
country: United States
facility: ARYS-0701 Site 8
state: Nevada
city: Las Vegas
country: United States
facility: ARYS-0701 Site 9
state: Nevada
city: New York
country: United States
facility: ARYS-0701 Site 10
state: New York
city: New York
country: United States
facility: ARYS-0701 Site 11
state: New York
city: New York
country: United States
facility: ARYS-0701 Site 4
state: New York
city: Raleigh
country: United States
facility: ARYS-0701 Site 12
state: North Carolina
city: Houston
country: United States
facility: ARYS-0701 Site 1
state: Texas
Study officials:
References:
citation: 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.