An observational study in Herpesviridae Infections, Herpes Simplex 1 and Varicella Zoster Virus Infection, sponsored by University of Pisa. Recruiting at 1 site in Italy. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by University of Pisa · Observational
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.
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
Exclusion Criteria:
Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections
Other: Pharmacokinetic analysis
Patients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections
Other: Pharmacokinetic analysis
Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring
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
Time frame: Six months since the beginning of acyclovir administration
Plan to share: No — Individual partecipant data will not be disclosed as per protocol and Ethics Committee requests. Protocol will be shared upon request, as well as the overall findings of the study
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University of Pisa