- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006131
Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
OBJECTIVES:
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE:
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77058
- Center for Clinical Studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
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%
--Prior/Concurrent Therapy--
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
--Patient Characteristics--
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Stephen K. Tyring, University of Texas
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/15324
- UTMB-97-120
- GW-R-24
- UTMB-GCRC-D085
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immunologic Deficiency Syndromes
-
Yonsei UniversityCompletedImmune DeficiencyKorea, Republic of
-
Yonsei UniversityCompleted
-
University of Colorado, DenverColorado Clinical & Translational Sciences InstituteRecruiting
-
Johann Wolfgang Goethe University HospitalUnknownImmune DeficiencyGermany
-
Zealandina AgencyCompleted
-
University of VirginiaCSL Behring; Jeffrey Modell FoundationCompletedImmune DeficiencyUnited States
-
Université Catholique de LouvainTerminatedCombined Inflammatory and Immunologic DefectBelgium
-
Green Cross CorporationParexel; Atlantic Research GroupCompletedImmunologic Deficiency SyndromesCanada, United States
-
Assistance Publique - Hôpitaux de ParisUnknownImmune Deficiency and Early BMF in ChildhoodFrance
-
National Cancer Institute (NCI)CompletedLymphoma | Leukemia | Neoplasm | Immunologic Deficiency SyndromeUnited States
Clinical Trials on Valacyclovir
-
Candel Therapeutics, Inc.Active, not recruitingProstate CancerUnited States, Puerto Rico
-
Radboud University Medical CenterCompletedBioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir (VALID-I)Varicella Zoster Virus Infection | Herpes Simplex Virus InfectionNetherlands
-
Dr. Reddy's Laboratories LimitedCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
GlaxoSmithKlineCompletedHerpes LabialisUnited States
-
University of MinnesotaCompletedEpstein-Barr Virus Infections | Cytomegalovirus Infections | Transplantation InfectionUnited States
-
Bristol-Myers SquibbCompletedHerpes Zoster | Shingles
-
National Institute of Allergy and Infectious Diseases...Glaxo WellcomeWithdrawnHIV Infections | Herpes Simplex | Chickenpox
-
GlaxoSmithKlineTerminatedHerpes GenitalisUnited States, Australia, Hong Kong
-
Yung Shin Pharm. Ind. Co., Ltd.CompletedHerpes ZosterTaiwan