Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
|ClinicalTrials.gov Identifier: NCT00006131|
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : May 24, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster Immunologic Deficiency Syndromes||Drug: Valacyclovir||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Study Start Date :||January 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006131
|United States, Texas|
|Center for Clinical Studies|
|Houston, Texas, United States, 77058|
|Study Chair:||Stephen K. Tyring||University of Texas|