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

NCT ID: NCT00209352

Last Updated: 2007-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1985-06-30

Study Completion Date

2004-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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VZV Infection After Bone Marrow Transplantation

Keywords

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Varicella Zoster Virus Infection VZV infection Oral Acyclovir Allogeneic Bone Marrow Transplantation Allogeneic Hematopoietic Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Acyclovir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Burroughs Wellcome

INDUSTRY

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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Michael Boeckh, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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):1800-5. doi: 10.1182/blood-2005-09-3624. Epub 2005 Nov 10.

Reference Type RESULT
PMID: 16282339 (View on PubMed)

Other Identifiers

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CA 18029

Identifier Type: -

Identifier Source: secondary_id

CA 15704

Identifier Type: -

Identifier Source: secondary_id

Burroughs Wellcome Fund

Identifier Type: -

Identifier Source: secondary_id

FHCRC Protocol 236.00

Identifier Type: -

Identifier Source: secondary_id

FHCRC IR 420

Identifier Type: -

Identifier Source: org_study_id