Clinical trial · Observational
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Herpes Simplex 1 | — | UNRESOLVED | — |
| Herpesviridae Infections | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Transplantation Infection | — | UNRESOLVED | — |
| Varicella Zoster Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharmacokinetic analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Intravenous Aciclovir
- description
- Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections
- interventionNames
- Other: Pharmacokinetic analysis
- label
- Oral Aciclovir
- description
- Patients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections
- interventionNames
- Other: Pharmacokinetic analysis
Primary outcomes (1)
- measure
- Percentage of patients who achieve an acyclovir minimum plasma concentration of 0.5 mg/L at steady state
- timeFrame
- Six months since the beginning of acyclovir administration
- description
- Percentage of patients who achieve an acyclovir minimum plasma concentration at steady state ≥0.5 mg/L, considered as an effective plasma concentration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMaximova 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