A Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients.

Cytomegalovirus Infection Clinical Trial

Official title:

Kinetics of Cytomegalovirus (CMV) Replication and CMV-specific Immune Reconstitution After Hematopoietic Stem Cell Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273143
• Other study ID #: 1052-05
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2006
• Last updated: May 20, 2011
• Start date: May 2005
• Est. completion date: April 2007

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is being done to determine how the body fights off a common virus known as Cytomegalovirus (CMV). CMV is a virus that commonly infects humans and causes disease in patients with compromised immune function such as those who receive organ and tissue transplant. By knowing how the human body responds to the infection, researchers will be able to develop better methods on how to prevent this infection.

Description:

This study is looking at the CMV virus in Hematopoietic stem cell donors and recipients. In the donor population, the study is looking at the participants blood to see if they contain cells that are active against the virus. Information about the donor will be obtained through an interview and through review of medical records. A blood sample will be drawn at the time of the donor's evaluation, which will take place in conjunction with the regular blood tests that are ordered. Participants of the study who are donors will only be involved in the study at the time of blood collection.

Participants who will be receiving hematopoietic stem cell transplantation will have data collected through an interview and review of medical records. Participants will have blood drawn prior to transplant, weekly for 12 weeks and then monthly for three months following transplant. In addition, if CMV disease develops during this period of time, blood will be drawn till the participant is cured for the disease. All blood draws for thes study will take place in conjunction with the regular routine blood work. Participants will be in the study for one year after transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Participants who will be undergoing blood marrow or stem cell transplant and donors that are 18 years of age or older, may be eligible to participate in this study.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the kinetics of CMV-specific immunity after HSCT.
Primary	To characterize the kinetics of CMV replication after HSCT.
Primary	To assess the degree of Epstein-Barr virus (EBV), human herpesvirus (HHV)-6 and HHV-7 replication after HSCT.