Clinical trial Recruiting at 1 site Observational Ages 6 Months to 18

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.

More Psycho-Oncology trials

Quick facts

Study typeObservational
Ages6 Months to 18 Years
SexAll
Enrollment200 (estimated)
SponsorUniversity of Pisa
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Trieste, TS)
StatusRecruiting
StartedSeptember 15, 2021
Main results expectedDecember 31, 2025
Study endsMarch 31, 2026
Registry record updatedJune 4, 2025
Trial IDNCT05198570 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.