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

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ClinicalTrials.gov Identifier: NCT00209352
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 21, 2007
Sponsor:
Collaborators:
Burroughs Wellcome
National Institutes of Health (NIH)
Information provided by:
Fred Hutchinson Cancer Research Center

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

Condition or disease Intervention/treatment Phase
VZV Infection After Bone Marrow Transplantation Drug: Acyclovir Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
Study Start Date : June 1985
Actual Study Completion Date : July 2004

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Primary Outcome Measures :
  1. VZV infection at one year

Secondary Outcome Measures :
  1. VZV infection after discontinuation of prophylaxis


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209352


Locations
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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
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Principal Investigator: Michael Boeckh, MD Fred Hutchinson Cancer Research Center

Publications of Results:
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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
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007
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:
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Infection
Communicable Diseases
Varicella Zoster Virus Infection
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Acyclovir
Antiviral Agents
Anti-Infective Agents