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

This study has been completed.
Sponsor:
Collaborators:
Burroughs Wellcome
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00209352
First received: September 13, 2005
Last updated: December 17, 2007
Last verified: December 2007
  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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Michael Boeckh, MD Fred Hutchinson Cancer Research Center
  More Information

Publications:
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 July 23, 2014