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


Phase 3
10 Years
N/A
Not Enrolling
Both
VZV Infection After Bone Marrow Transplantation

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

VZV infection at one year

Principal Investigator

Michael Boeckh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

FHCRC IR 420

NCT ID:

NCT00209352

Start Date:

June 1985

Completion Date:

July 2004

Related Keywords:

  • VZV Infection After Bone Marrow Transplantation
  • Varicella Zoster Virus Infection
  • VZV infection
  • Oral Acyclovir
  • Allogeneic Bone Marrow Transplantation
  • Allogeneic Hematopoietic Cell Transplantation
  • Herpes Zoster
  • Virus Diseases

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109