Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant

This study has been completed.

First Received on September 13, 2005. Last Updated on December 17, 2007 History of Changes

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborators:	Burroughs Wellcome National Institutes of Health (NIH)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00209352

Purpose

The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.

Condition	Intervention	Phase
VZV Infection After Bone Marrow Transplantation	Drug: Acyclovir	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Chickenpox Shingles

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

VZV infection at one year

Secondary Outcome Measures:

VZV infection after discontinuation of prophylaxis

Estimated Enrollment:	120
Study Start Date:	June 1985
Study Completion Date:	July 2004

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

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209352

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

Burroughs Wellcome

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Michael Boeckh, MD

Fred Hutchinson Cancer Research Center

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00209352 History of Changes
Other 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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Fred Hutchinson Cancer Research Center:

Varicella Zoster Virus Infection
VZV infection
Oral Acyclovir
Allogeneic Bone Marrow Transplantation
Allogeneic Hematopoietic Cell Transplantation

Additional relevant MeSH terms:

Herpes Zoster
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Acyclovir

Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012