The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant...
Date First Received: September 13, 2005
Last Updated: December 17, 2007
Verified by: Fred Hutchinson Cancer Research Center, December 2007
Clinical Trial Phase: Phase 3 | Start Date: June 1985
Overall Status: Completed
Estimated Enrollment: 120
Brief Summary
Official Title: “Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant”
Condition Keyword(s):
Intervention(s):
The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.
Study Type: Interventional
Study Design: Other, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Acyclovir
Outcome Measures for this Clinical Trial
Primary Measures
- VZV infection at one year
Secondary Measures
- VZV infection after discontinuation of prophylaxis
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 10 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Fred Hutchinson Cancer Research Center
Overall Clinical Trial Officials and Contacts
Michael Boeckh, MD Principal Investigator Fred Hutchinson Cancer Research Center
Related Publications
Citations Reporting Results
Boeckh M, Kim HW, Flowers ME, Meyers JD, Bowden RA. Long-term acyclovir for prevention of varicella zoster virus disease after allogeneic hematopoietic cell transplantation--a randomized double-blind placebo-controlled study. Blood. 2006 Mar 1;107(5):1800-5. Epub 2005 Nov 10.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209352
Study ID Number: FHCRC IR 420
ClinicalTrials.gov Identifier: NCT00209352
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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