Herpes Zoster Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03120364 -
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
|
Phase 3 | |
| Completed |
NCT01165203 -
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
|
Phase 2 | |
| Recruiting |
NCT06088745 -
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
|
Phase 3 | |
| Completed |
NCT01385566 -
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
|
Phase 1 | |
| Completed |
NCT01911065 -
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
|
Phase 4 | |
| Completed |
NCT01137669 -
ZOSTAVAX® in Renal Transplant Patients
|
Phase 1 | |
| Completed |
NCT00550745 -
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
|
Phase 4 | |
| Completed |
NCT01132729 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
|
N/A | |
| Completed |
NCT01132716 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
|
N/A | |
| Completed |
NCT02852876 -
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
|
Phase 1 | |
| Completed |
NCT00231816 -
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
|
Phase 3 | |
| Completed |
NCT05082688 -
Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)
|
Phase 2 | |
| Completed |
NCT04099706 -
Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
|
N/A | |
| Active, not recruiting |
NCT04091451 -
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles
|
Phase 3 | |
| Completed |
NCT02519855 -
Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
|
Phase 3 | |
| Completed |
NCT04523246 -
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
|
Early Phase 1 | |
| Completed |
NCT05047770 -
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
|
Phase 3 | |
| Completed |
NCT03314103 -
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
|
Phase 3 | |
| Completed |
NCT01527370 -
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
|
Phase 3 | |
| Completed |
NCT01954251 -
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
|
Phase 3 |