CMX001 in Post-transplant Patients With BK Virus Viruria

Trial Summary

Renal and hematopoetic stem cell patients with BK virus viruria post-transplant will be enrolled and randomized to 2 weeks of dosing with CMX001 or placebo. Safety assessments including clinical laboratory evaluations and vital signs measurements will be performed and blood samples will be collected to measure the amount of study drug in the blood. Viral levels will be measured in the blood and urine.

Eligibility

• Urine levels of BKV ≥ 10^4 copies/mL.
• Renal transplant patients have either
• urine levels of BKV DNA ≥ 10^4 copies/mL without viremia OR
• plasma levels of BKV DNA < 10^4 copies/mL (with our without viruria)
• Renal transplant patients must be at least 28 days post-transplant, have no evidence
  of graft reject and be on a stable immunosuppressant regimen.
• Stem cell transplant patients must be at least 3 days post documentation of
  successful engraftment.
• Able to swallow tablets.

• Currently nursing or pregnant females.
• Unstable or poorly controlled diabetes.
• Patients who received aminoglycosides (IV) or NSAIDS (except as given for
  cardioprotective treatment) within 7 days prior to enrollment.
• Patients who received leflunomide, cidofovir or any other medication for treatment
  of BK virus within 14 days prior to enrollment.
• Positive for active CMV infection or CMV disease.
• Patients who are HIV positive.
• Patients with active HCV or HBV infection.
• Renal transplant patients who were D+/R- for CMV at the time of transplant.
• Stem cell transplant patients who were D-/R+ for CMV at the time of transplant.

Detailed Description

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

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