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

Phase 3CompletedNCT00209352

Fred Hutchinson Cancer Center120 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

120

Conditions

VZV Infection After Bone Marrow Transplantation

Interventions

AcyclovirDRUG

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

VZV infection at one year

Secondary Outcomes

VZV infection after discontinuation of prophylaxis

Data from ClinicalTrials.gov

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