Recruiting

NCT Number: NCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. * Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. * Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection. * Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. * Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children. * Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

Recruiting

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Key information

Conditions

Herpesviridae Infections DNA Virus Infections Herpes Simplex 1 Infections Neoplasms Oncology Transplantation Infection Varicella Zoster Virus Infection Virus Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health

Trieste, TS, 34137, Italy

Location status: Recruiting

Location contact

Antonello Di Paolo, MD

SUB_INVESTIGATOR

Natalia Maximova, MD

CONTACT

[email protected]

About this study

Herpesvirus infections may lead to severe disease with a high risk of complications and mortality in hematopoietic stem cell transplant (HSCT) recipients, or in patients receiving high-intensity chemotherapy for hematological malignancies. That risk is mainly associated with the worldwide prevalence of herpes simplex virus 1 (HSV-1) that increases consistently with age. In particular, the majority of adult leukemia patients are HSV seropositive, while allogeneic HSCT recipients had post-transplant HSV reactivation. It is worth noting that in the first post-transplant year, symptomatic varicella-zoster virus (VZV) reactivation has a rate of 13% - 55% in adult recipients. Similar percentages of children receiving HSCT had VZV reactivation, being also possible a disseminated infection in 10% of children. However, thanks to antiviral prophylaxis in seropositive HSCT recipients, the rate of infection has significantly dropped.

Among the drugs most used for treatment and prophylaxis of HSV/VZV infections among children who are HSCT recipients or undergo a high-intensity chemotherapy, acyclovir represents the drug of choice. Although its role in preventing and treating herpes virus infections, the pharmacokinetics of acyclovir is highly variable, especially in patients in intensive care units, in those who have organ dysfunction, or in children. In particular, information about the optimal use of acyclovir in children with malignancies is limited.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacokinetic analysis

Other

Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring

Primary outcomes

Percentage of patients who achieve an acyclovir minimum plasma concentration of 0.5 mg/L at steady state

Time frame: Six months since the beginning of acyclovir administration

Percentage of patients who achieve an acyclovir minimum plasma concentration at steady state ≥0.5 mg/L, considered as an effective plasma concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Maximova, MD

CONTACT

[email protected]

040 378 5111 ext. 565

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Collaborators

IRCCS Burlo Garofolo

Registry information

Official study title

Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2026
First posted: Jan 20, 2022
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed