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Updated: Jun 6, 2026
Assays for the Identification of Novel Antivirals against Bluetongue Virus
Published on: October 11, 2013
A randomized, placebo-controlled, dose-escalation phase I/II multicenter trial of low-dose cidofovir for BK
Hannah Imlay1, John W Gnann2, James Rooney3
1Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.
Background:
BK polyomavirus-associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).
Methods:
We report the results of a phase I/II, double-blind, placebo-controlled randomized dose-escalation trial of cidofovir in KTRs with biopsy-confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow-up through day 49.
Results:
The trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group).
Conclusions:
These preliminary results indicate that low-dose cidofovir was safe and tolerated but had no significant BKPyV-specific antiviral effect in KTRs with BKPyVAN.
Insights
Low-dose cidofovir showed safety in kidney transplant recipients with BK polyomavirus-associated nephropathy (BKPyVAN). However, it did not demonstrate significant antiviral effects against BK polyomavirus (BKPyV) in this patient group.
Area of Science:
- Nephrology
- Virology
- Transplant Medicine
Background:
- BK polyomavirus-associated nephropathy (BKPyVAN) is a significant cause of kidney transplant dysfunction.
- Effective treatments for BKPyVAN are currently lacking.
- Cidofovir has shown potential activity against BK polyomavirus (BKPyV) in prior studies.
Purpose of the Study:
- To evaluate the safety and efficacy of low-dose cidofovir in kidney transplant recipients (KTRs) with BKPyVAN.
- To assess the antiviral effect of cidofovir on BKPyV DNAemia.
Main Methods:
- A phase I/II, double-blind, placebo-controlled randomized dose-escalation trial was conducted.
- KTRs with biopsy-confirmed BKPyVAN and eGFR ≥30 mL/min received intravenous cidofovir (0.25 or 0.5 mg/kg) or placebo.
- Treatment was administered on days 0, 7, 21, and 35, with follow-up through day 49.
Main Results:
- The trial was stopped early due to slow patient accrual.
- Cidofovir was found to be safe and well-tolerated at the studied doses.
- No significant difference in BKPyV DNAemia reduction was observed between cidofovir and placebo groups.
Conclusions:
- Low-dose cidofovir is safe and tolerable for KTRs with BKPyVAN.
- Cidofovir did not demonstrate a significant BKPyV-specific antiviral effect in this trial.
- Further research may be needed to explore alternative dosing or treatment strategies.
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