Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date December 21, 2007
Study Start Date  ICMJE June 1985
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
VZV infection at one year
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00209352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
VZV infection after discontinuation of prophylaxis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
Official Title  ICMJE Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
Brief Summary The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE VZV Infection After Bone Marrow Transplantation
Intervention  ICMJE Drug: Acyclovir
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 14, 2005)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209352
Other Study ID Numbers  ICMJE FHCRC IR 420
CA 18029
CA 15704
Burroughs Wellcome Fund
FHCRC Protocol 236.00
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • Burroughs Wellcome
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Michael Boeckh, MD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP