An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria

Exclusion Criteria

• •1. Is not able to comply with study procedures and dosing.
• •2. Has psychiatric instability.
• •3. Has an active systemic infection including Hepatitis B or C, HIV, or on anti-viral therapy within seven days of entering the study. Note however, that the subjects may be taking ganciclovir, valaciclovir, acyclovir and valganciclovir and therefore these are not exclusionary antiviral medications.
• •4. Has BK viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory), or has had a single episode of BK viremia. (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory or the local laboratory),
• •5. Has a cancer diagnosis within past five years with potential for recurrence.
• •6. Has received experimental drug within past 3 months.
• •7. Is receiving immune suppressive drug other than those listed above calcineurin inhibitor, mycophenolate/azathioprine and +/- corticosteroid)
• •8. Is a woman of child bearing potential or is a male with female partner of child bearing potential who is unwilling to use reliable contraception.
• •9. Has any neurologic abnormalities including peripheral neuropathy.
• •10. Is receiving concomitant therapy with drug known to have hepatotoxic risk.
• •11. Has known or suspected liver disease or current alcohol abuse.