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Virus Therapy

Cidofovir for Hemorrhagic Cystitis

Phase 2

Waitlist Available

Led By Borje S. Andersson, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >/= 6 years

HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC per NCI criteria) and positive BKV in urine >1x103 DNA copies/ml

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will test whether adding cidofovir to the current standard of care for hemorrhagic cystitis improves symptoms caused by the BK virus, as well as studying the safety of cidofovir.

Who is the study for?

This trial is for individuals aged 6 or older who have a bladder infection known as hemorrhagic cystitis, caused by the BK virus. Participants must show symptoms and have a certain level of BK virus in their urine. They cannot join if they've used cidofovir before, had specific treatments like formalin, have low kidney function, or are using certain other medications.Check my eligibility

What is being tested?

The study aims to see if adding cidofovir to standard care helps with symptoms of hemorrhagic cystitis better than standard care alone. It's also looking at how safe cidofovir is when used this way.See study design

What are the potential side effects?

Cidofovir may cause kidney problems, irritation where it's injected, nausea, and eye issues (like inflammation). There might be other side effects that researchers will monitor during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 6 years old or older.

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I have mild bladder symptoms from a stem cell transplant and tested positive for BK virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients with Microbiologic Response

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care + CidofovirExperimental Treatment1 Intervention

Cidofovir 0.5 mg/kg IV 3 x week for 4 weeks

Group II: No CidofovirActive Control1 Intervention

Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cidofovir

1994

Completed Phase 4

~480

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,754 Total Patients Enrolled

Borje S. Andersson, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Cidofovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01295645 — Phase 2

Transplant Infection Research Study Groups: Standard of Care + Cidofovir, No Cidofovir

Transplant Infection Clinical Trial 2023: Cidofovir Highlights & Side Effects. Trial Name: NCT01295645 — Phase 2

Cidofovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01295645 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precedent has been established in regard to Cidofovir research?

"Presently, there is 1 ongoing clinical trial investigating the efficacy of Cidofovir and no Phase 3 trials. These studies are primarily based in Houston, Texas with a single other site participating."

Answered by AI

What is the ceiling for participants in this medical examination?

"Unfortunately, this clinical trial is no longer enrolling participants. The original posting was March 1st 2011 and the study's last update occurred October 11th 2022. However, 41 other studies for patients with cystitis are still active as well as a single Cidofovir-focused medical trial which is open to new members."

Answered by AI

To what medical maladies is Cidofovir typically administered?

"Cidofovir is predominantly administered to patients with acquired immunodeficiency syndrome, but it may also be beneficial in the treatment of acyclovir, variola major (smallpox), and cytomegalovirus retinitis."

Answered by AI

Is this experiment still open to volunteers?

"At the present moment, this trial has stopped accepting participants. This study was initially posted on March 1st 2011 and last updated October 11th 2022. For those who are still looking for a clinical trial to join, there are 41 studies recruiting patients with cystitis and another one seeking candidates willing to test Cidofovir."

Answered by AI

What have been the reported adverse effects of Cidofovir on human health?

"Cidofovir has been granted a safety score of 2 due to the limited amount of clinical evidence concerning its efficacy, despite there being some data available regarding its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

2011. "Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01295645.