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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center Burroughs Wellcome National Institutes of Health (NIH) |
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Information provided by: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00209352 |
The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.
Condition | Intervention | Phase |
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VZV Infection After Bone Marrow Transplantation |
Drug: Acyclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant |
Estimated Enrollment: | 120 |
Study Start Date: | June 1985 |
Study Completion Date: | July 2004 |
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.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Michael Boeckh, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | FHCRC IR 420, CA 18029, CA 15704, Burroughs Wellcome Fund, FHCRC Protocol 236.00 |
Study First Received: | September 13, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00209352 |
Health Authority: | United States: Food and Drug Administration |
Varicella Zoster Virus Infection VZV infection Oral Acyclovir Allogeneic Bone Marrow Transplantation Allogeneic Hematopoietic Cell Transplantation |
Virus Diseases Herpes Zoster Acyclovir Chickenpox |
DNA Virus Infections Chicken pox Varicella Zoster Herpesviridae Infections |
Anti-Infective Agents Communicable Diseases Therapeutic Uses |
Infection Antiviral Agents Pharmacologic Actions |