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

Completed

• Conditions: Cytomegalovirus Infection

• Registration Number: NCT00273143
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-20
• Last Update Posted: 2011-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the kinetics of CMV-specific immunity after HSCT.
To characterize the kinetics of CMV replication after HSCT.
To assess the degree of Epstein-Barr virus (EBV), human herpesvirus (HHV)-6 and HHV-7 replication after HSCT.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States