NCT00006131

Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Herpes Zoster
• Immunologic Deficiency Syndromes

Interventions

Type	Name	Description
DRUG	Valacyclovir

Timeline

• Start date: 1997-01-01
• First posted: 2000-08-04
• Last updated: 2007-05-24

Locations

1 site across 1 country: United States