Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster V... | NCT00209352

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

NCT00209352

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

Dec 21, 2007Estimated

Enrollment

120

Phase

Phase 3

Conditions

VZV Infection After Bone Marrow Transplantation

Interventions

Acyclovir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1985

Primary Completion Date

Not provided

Completion Date

Jul 2004Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2007

Last Update Posted Date

Dec 21, 2007Estimated

Name	Class
Burroughs Wellcome	INDUSTRY
National Institutes of Health (NIH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Acyclovir	Drug

Measure	Description	Time Frame
VZV infection at one year

Measure	Description	Time Frame
VZV infection after discontinuation of prophylaxis

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Boeckh, MD	Fred Hutchinson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutchinson Cancer Research Center		Seattle	Washington	98109	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16282339	Result	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.

ID	Type	Description	Link
CA 18029
CA 15704
Burroughs Wellcome Fund
FHCRC Protocol 236.00

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574