Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00831103
Eligibility Criteria:
Inclusion Criteria:
* Male and female adults at least 18 years of age
* Patients with signs and symptoms consistent with acute herpes zoster disease, namely, a dermatomal vesicular rash which may be preceded by pain and parasthesias in the days before vesicular eruption
* Herpes Zoster associated rash present for ≤ 72 hours
* Patients who are deemed to be immunocompetent based on history and physical exam
Exclusion Criteria:
* Females who are pregnant or nursing
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease including HIV or HBsAg positivity
* Chronic genital herpes
* Patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation
* Previous vaccinations against Herpes Zoster
* Patients with \> 50% of vesicles crusted at screen
* Patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation
* Patients with a history of congenital, acquired, or corticosteroid induced immunodeficiency, including malignancy, significantly impaired renal function (creatinine clearance \< 50 cc/min), and impaired hepatic function (ALT or AST levels \> 3 times the upper limit of normal)
* QTc \> 500msec
* Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir
* Patients with gastrointestinal dysfunction that might interfere with drug absorption
* Patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00831103
Study Brief:
Protocol Section:
NCT00831103