Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
Information source: Fred Hutchinson Cancer Research Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: VZV Infection After Bone Marrow Transplantation
Intervention: Acyclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s):
Michael Boeckh, MD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center
Summary
The objective of this study is to prevent reactivation of herpes zoster during the first year
after transplant.
Clinical Details
Official title: Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
Study design: Other, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: VZV infection at one year
Secondary outcome: VZV infection after discontinuation of prophylaxis
Detailed description:
Herpes zoster infection occurs in 30% of allogeneic hematopoietic cell transplant (HCT)
recipients who had a history of varicella zoster virus (VZV) infection. A safe and effective
prevention strategy has not been established.
77 marrow allograft recipients at risk for VZV reactivation were randomized to oral acyclovir
800 mg twice daily or placebo given from day 30 until day 365 and were followed for toxicity
and clinical evidence of herpes zoster infection.
Eligibility
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 10 years or older
- Both sex (male or female)
- Allogeneic transplant patient for hematologic malignancy or aplastic anemia
Exclusion Criteria:
- Previous intolerance to acyclovir
- Patients who are unavailable for follow-up
- Patients in whom drug compliance may be a problem
- Evidence of active VZV infection
- VZV infection in the initial 1 month after transplant
- Pregnant women, lactating women, or those not using adequate contraception
- Creatinine > 3. 0 mg/dl.
Locations and Contacts
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States
Additional Information
Starting date: June 1985
Ending date: July 2004
Last updated: December 17, 2007
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