Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

NCT05198570 | Recruiting

• 1 other identifier: RC_10/20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Herpesviridae Infections; Herpes Simplex 1; Varicella Zoster Virus Infection; Transplantation Infection; Oncology

Keywords

Hematopoietic stem cell transplantation; Herpes virus infections; Aciclovir; Children; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

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

  Six months since the beginning of acyclovir administration

Study Arms (2)

Intravenous Aciclovir

Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections

Other: Pharmacokinetic analysis

Oral Aciclovir

Patients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections

Other: Pharmacokinetic analysis

Interventions

Pharmacokinetic analysis OTHER

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

Intravenous Aciclovir; Oral Aciclovir

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 0-18 years, affected by hematological malignancies, undergoing ACV prophylaxis or treatment for HSV-VZV infection routinely during allogeneic HSCT or ACV treatment during high-intensity chemotherapy, for who a therapeutic drug monitoring (TDM) protocol is available. Patients receive ACV as a standard 1-h intravenous infusion or through the oral administration of valaciclovir

You may qualify if:

• 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

You may not qualify if:

• lack of signed informed consent
• lack of TDM for ACV
• unavailable patient's demographic characteristics

Sponsors & Collaborators

• University of Pisa: lead
• IRCCS Burlo Garofolo: collaborator

Study Sites (1)

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

Trieste, TS, 34137, Italy

RECRUITING

Related Publications (1)

• Maximova N, Nistico D, Luci G, Simeone R, Piscianz E, Segat L, Barbi E, Di Paolo A. Population Pharmacokinetics of Intravenous Acyclovir in Oncologic Pediatric Patients. Front Pharmacol. 2022 Apr 14;13:865871. doi: 10.3389/fphar.2022.865871. eCollection 2022.

  PMID: 35496277 RESULT

MeSH Terms

Conditions

Herpesviridae Infections; Varicella Zoster Virus Infection; Neoplasms

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Natalia Maximova, MD

  IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Maximova, MD

CONTACT

040 378 5111; natalia-maximova@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacology

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 20, 2022
• Study Start: September 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)