Cytomegalovirus
Conditions
Brief summary
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
Interventions
DRUGCMV Immune globulin
CMV IvIg 150mg/kg x 6 doses
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection * receiving no more than 48 hrs of therapy prior to study enrollment
Exclusion criteria
* serum creatinine \<2.2 at the time of enrollment * no prior use of CMV IgG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMV viral load | 12 months |
Countries
United States
Outcome results
None listed