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

VZV Infection After Bone Marrow Transplantation Clinical Trial

Official title:

Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209352
• Other study ID #: FHCRC IR 420
• Secondary ID: CA 18029CA 15704
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 17, 2007
• Start date: June 1985
• Est. completion date: July 2004

Study information

• Verified date: December 2007
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Communicable Diseases
• Herpes Zoster
• Infection
• Virus Diseases
• VZV Infection After Bone Marrow Transplantation

Intervention

Drug:
• Acyclovir

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Burroughs Wellcome, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VZV infection at one year
Secondary	VZV infection after discontinuation of prophylaxis