Status:
COMPLETED
Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Lahey Clinic
Conditions:
CMV Disease
Viral Resistance
Eligibility:
All Genders
18+ years
Brief Summary
CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usual...
Detailed Description
CMV infection occurs most frequently in the first three months following transplantation and following treatment for acute rejection; both instances can be related to relatively high levels of immunos...
Eligibility Criteria
Inclusion
- 1\) Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported.
- \-
Exclusion
- Patients receiving systemic therapy for acute opportunistic infection at time of enrollment
- Patients receiving investigational drugs
- Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers
- Patients with active substance abuse or other condition that would impair compliance
- Patients who are unable to give informed consent
- Any patient with a creatinine clearance \< 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (\>40) as would occur with resolving ATN.
- Persistent ANC \< 1,000 for 2 consecutive weeks despite treatment with G-CSF
- Any female patient who plans to become pregnant within one year
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
End Date :
July 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00225394
Start Date
October 1 2003
End Date
July 1 2006
Last Update
September 23 2005
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Lahey Clinic Transplant
Burlington, Massachusetts, United States, 01803
3
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
4
Rhode Island Hospital
Providence, Rhode Island, United States, 02903