Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
|First Submitted Date ICMJE||August 3, 2000|
|First Posted Date ICMJE||August 4, 2000|
|Last Update Posted Date||May 24, 2007|
|Start Date ICMJE||January 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006131 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster|
|Official Title ICMJE||Not Provided|
I. Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised patients with uncomplicated herpes zoster.
II. Compare quality of life, pain, and medical resource utilization in patients treated with these 2 regimens.
This is a randomized, double blind study.
Patients are randomized to one of two treatment arms.
Arm I: Patients receive standard dose oral valacyclovir three times a day on Days 1-7.
Arm II: Patients receive higher dose oral valacyclovir three times a day on Days 1-7.
Both arms: Patients begin treatment within 72 hours after onset of zoster rash.
Quality of life is assessed on Days 1, 14, and 28 during study and then every 4 weeks through Week 24. Pain is assessed on Days 1-28 during study, and then weekly through Week 24. Medical resource utilization is assessed on Days 1, 8, 14, and 18 during study and then every 4 weeks through Week 24.
Patients are followed every 4 weeks through Week 24.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Valacyclovir|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||66|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PROTOCOL ENTRY CRITERIA:
Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within 72 hours after onset of zoster rash
No evidence of cutaneous or visceral dissemination of herpes zoster infection; cutaneous dissemination defined as at least 20 discrete lesions outside adjacent dermatomes
Must have immune dysfunction caused by any of the following: congenital immune deficiency; active malignancy of any type; collagen vascular diseases; organ or bone marrow transplantation; HIV infection; severe atopic dermatitis; received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within past 3 months
CD4 count at least 50%
Biologic therapy: Greater than 9 months since prior bone marrow transplantation
Surgery: Greater than 9 months since prior liver or heart transplantation
Other: At least 4 weeks since prior topical or systemic anti-varicella zoster virus (anti-VZV) medications; no concurrent systemic agents with anti-VZV activity from enrollment to Day 10; no concurrent probenecid from 24 hours before the first dose of study drug until Day 10
Hepatic: AST or ALT no greater than 5 times upper limit of normal
Renal: Creatinine clearance at least 30 mL/min
Other: Not pregnant or nursing; negative pregnancy test; fertile patients must use effective contraception; no history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00006131|
|Other Study ID Numbers ICMJE||199/15324
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Center for Research Resources (NCRR)|
|Collaborators ICMJE||University of Texas|
|PRS Account||National Center for Research Resources (NCRR)|
|Verification Date||December 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP