VZV Infection After Bone Marrow Transplantation
Conditions
Keywords
Varicella Zoster Virus Infection, VZV infection, Oral Acyclovir, Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Cell Transplantation
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.
Interventions
DRUGAcyclovir
Sponsors
Burroughs Wellcome
National Institutes of Health (NIH)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VZV infection at one year | — |
Secondary
| Measure | Time frame |
|---|---|
| VZV infection after discontinuation of prophylaxis | — |
Countries
United States
Outcome results
None listed