Trial record 6 of 8 for:    Boeckh

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

This study has been completed.
Burroughs Wellcome
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: September 13, 2005
Last updated: December 17, 2007
Last verified: December 2007

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 3

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:

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.


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

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.
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Please refer to this study by its identifier: NCT00209352

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Burroughs Wellcome
Principal Investigator: Michael Boeckh, MD Fred Hutchinson Cancer Research Center
  More Information

Publications: 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:
Communicable Diseases
Herpes Zoster
Virus Diseases
DNA Virus Infections
Herpesviridae Infections
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on May 21, 2015