NCT00209352

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 1985

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1985

Completed
19.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

September 13, 2005

Last Update Submit

December 17, 2007

Conditions

VZV Infection After Bone Marrow Transplantation

Keywords

Varicella Zoster Virus InfectionVZV infectionOral AcyclovirAllogeneic Bone Marrow TransplantationAllogeneic Hematopoietic Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • VZV infection at one year

Secondary Outcomes (1)

  • VZV infection after discontinuation of prophylaxis

Interventions

AcyclovirDRUG

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Both sex (male or female)
  • Allogeneic transplant patient for hematologic malignancy or aplastic anemia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 16282339RESULT

MeSH Terms

Conditions

Varicella Zoster Virus Infection

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Michael Boeckh, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 1985

Study Completion

July 1, 2004

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(1)