Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
This study will evaluate the reliability of a new test called Real-Time Polymerase chain
 reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course
 of CMV disease in patients who have recently had a bone marrow transplant. The test's
 effectiveness will be compared with that of the "pp65 antigenemia assay" now routinely used
 for this purpose.

 CMV is a common virus that is transmitted from person to person by close personal contact. In
 most healthy people, CVM can remain in the body indefinitely without causing any harm. But,
 in people with weakened immune systems-including those who have just undergone bone marrow
 transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are
 available to treat this infection, however. Optimum treatment depends on early and accurate
 detection.

 Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH
 Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase
 1, patients will have blood drawn for both RT PCR and antigenemia testing once before the
 bone marrow transplantation and then weekly for the first 100 days after the transplant.
 During Phase 2-which begins immediately after the end of phase 1 and continues for one year
 after the transplant-blood samples for both tests will be drawn up to once a week. The
 samples for both tests will be collected at the same time and will be taken through a
 catheter (a thin flexible tube inserted into a vein) that has already been placed for the
 transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what
 is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over
 the course of the 1-year study.

 It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV
 infection and predicting disease development, thus enabling doctors to plan early and
 effective treatment.
Currently, it is the standard of care to use the pp65 antigenemia assay to guide
 anti-cytomegalovirus therapy in hematopoietic stem cell transplant patients. Nevertheless,
 over the past two years at our institution, only approximately 10% of antigenemia-positive
 patients went on to develop overt CMV disease and only 22% of patients with documented
 clinical CMV disease had a positive antigenemia test in the two weeks prior to diagnosis
 (data on file).

 Recently, a test called CMV Real-Time PCR has been applied to the diagnosis of CMV infection.
 Preliminary data suggests that this test may be of value in detecting active CMV replication.
 Thus, it may be able to predict CMV disease and help guide antiviral therapy.

 We propose a prospective observational study comparing CMV Real-Time PCR test and pp65
 antigenemia. This will be done by taking an extra blood sample (approximately 5 mL) for the
 CMV Real-Time PCR test from hematopoietic stem cell transplant patients whenever a sample for
 the pp65 antigenemia test is drawn. No separate venipunctures are anticipated. These samples
 will be drawn on an approximately weekly basis during the first 100 days post-transplant, as
 is currently done for the pp65 antigenemia test alone. Additionally, at any time blood is
 drawn for the pp65 antigenemia test after 100 days, we will also take blood for the CMV
 Real-Time PCR test, up to one year post-transplant. The results of the CMV Real-Time PCR test
 will not be used to guide therapy. Overt CMV disease will be identified via real-time chart
 review and patient interviews by one of the investigators in the study. The primary goal of
 the study is to evaluate the ability of the CMV Real-Time PCR test to accurately detect
 active CMV viral proliferation and predict ultimate overt CMV disease as compared to the
 currently-used pp65 antigenemia test.
Male or female patients that are 10 years of age or older up to 80 years of age are
 included.

 Patients must be enrolled in a protocol at the NIH Clinical Center that will result in the
 patient receiving an allogeneic stem cell transplant (A-HSCT).

 Patients who have not yet received a pre-transplant chemotherapy and radiation therapy
 conditioning regimen are eligible.

 Patients must not have a negative IgG serologic test for CMV and whose hematopoietic stem
 cell donor also has a negative IgG serologic test as reported by the Bone Marrow Transplant
 staff.

 Patients must not have documentation of prior cytomegalovirus antigenemia or disease prior
 to starting the conditioning regimen.