Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
December 17, 2007 updated by: Fred Hutchinson Cancer Center
Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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VZV infection at one year
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Secondary Outcome Measures
Outcome Measure |
|---|
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VZV infection after discontinuation of prophylaxis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Boeckh, MD, Fred Hutchinson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 1985
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
December 21, 2007
Last Update Submitted That Met QC Criteria
December 17, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHCRC IR 420
- CA 18029
- CA 15704
- Burroughs Wellcome Fund
- FHCRC Protocol 236.00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.