- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00209352
Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
Study Overview
Status
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
Enrollment
Phase
- Phase 3
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Secondary Outcome Measures
Outcome Measure |
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VZV infection after discontinuation of prophylaxis
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Boeckh, MD, Fred Hutchinson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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