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

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: VZV Infection After Bone Marrow Transplantation

Intervention: Acyclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Michael Boeckh, MD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center

Summary

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

Clinical Details

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

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

Primary outcome: VZV infection at one year

Secondary outcome: VZV infection after discontinuation of prophylaxis

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.

Eligibility

Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States
Additional Information

Starting date: June 1985
Last updated: December 17, 2007

Page last updated: August 23, 2015

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