Understanding how intravenous acyclovir works in children with cancer
Official title: Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
Run by University of Pisa · NCT05198570 · Data updated 2026-11-12
This study is trying to understand how the drug acyclovir works in children with cancer to see if it can help protect them from serious herpesvirus infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Months to 18 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Pisa Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Trieste, TS) |
| Status | Recruiting |
| Started | September 15, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | March 31, 2026 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT05198570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children with hematological malignancies or those receiving HSCT who require acyclovir for herpesvirus infection prophylaxis or treatment.
✕Probably not a fit
Patients who do not require acyclovir treatment or those without hematological malignancies or HSCT are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the pharmacokinetics of intravenous acyclovir in pediatric patients with hematological malignancies or those undergoing hematopoietic stem cell transplantation. It aims to analyze how the drug behaves in the body, particularly in children, who may experience significant variability in drug metabolism. By monitoring drug levels and optimizing treatment protocols, the study seeks to improve outcomes for children at high risk of herpesvirus infections. The research is crucial for tailoring acyclovir therapy to enhance its effectiveness and safety in vulnerable pediatric populations.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer acyclovir dosing strategies for children with cancer, reducing the risk of herpesvirus infections.
How similar studies have gone: While the pharmacokinetics of acyclovir has been studied in adults, this specific focus on pediatric patients with malignancies is relatively novel and underexplored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Hematological malignancies * HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or * Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment. * Intravenous or oral ACV dosing * Active/available a therapeutic drug monitoring (TDM) protocol for ACV * Informed consent signed by patient's parents Exclusion Criteria: * lack of signed informed consent * lack of TDM for ACV * unavailable patient's demographic characteristics
Where it's running
-
IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health
Trieste, Ts, Italy Recruiting
Study contacts
- Principal investigator: Natalia Maximova, MD — IRCCS Burlo Garofolo
- Study coordinator: Natalia Maximova, MD
- Email: natalia-maximova@burlo.trieste.it
- Phone: 040 378 5111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.