VZV Infection After Bone Marrow TransplantationPhase 3NCT00209352
Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
A Phase 3 study testing Acyclovir in people with VZV Infection After Bone Marrow Transplantation, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- VZV Infection After Bone Marrow Transplantation
- What is being tested?
- Acyclovir
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1985to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 10 years or older
- Both sex (male or female)
- Allogeneic transplant patient for hematologic malignancy or aplastic anemia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
The objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.
Read the 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.
- Being tested
- Acyclovir
- Keywords
- Varicella Zoster Virus Infection, VZV infection, Oral Acyclovir, Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Cell Transplantation
- Medical subject headings
- Varicella Zoster Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
VZV infection at one year
Secondary outcomes (1)
VZV infection after discontinuation of prophylaxis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 1985
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VZV Infection After Bone Marrow TransplantationStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Burroughs Wellcome, National Institutes of Health (NIH)
- Investigators
- Michael Boeckh, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209352
- Sponsor's protocol ID
- FHCRC IR 420
- Other IDs
- CA 18029, CA 15704, Burroughs Wellcome Fund, FHCRC Protocol 236.00
- Status last verified
- Dec 2007
- First submitted
- 13 Sep 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Publications
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.
PubMed 16282339
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Long-Term Oral Acyclovir Usage to Prevent Varicella Zoster Virus Infection After Allogeneic Bone Marrow Transplant
- ClinicalTrials.gov ID
- NCT00209352
- Acronym / sponsor ID
- FHCRC IR 420
- Keywords
- Varicella Zoster Virus Infection, VZV infection, Oral Acyclovir, Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Cell Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Burroughs Wellcome, National Institutes of Health (NIH)
- Study start
- Jun 1985
- Study completion
- Jul 2004 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 10 years or older
- Both sex (male or female)
- Allogeneic transplant patient for hematologic malignancy or aplastic anemia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir | Drug | – |
Primary outcome
VZV infection at one year
1 secondary outcome
VZV infection after discontinuation of prophylaxis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
- Results publication: PubMed 16282339Boeckh 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Boeckh, MD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acyclovir in people with VZV Infection After Bone Marrow Transplantation, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VZV infection at one year. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00209352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.