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.
17 studies on the registry are indexed under Varicella Zoster Virus Infection; 3 are open to participants now.
Browse Varicella Zoster Virus Infection studies →University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Compared within Varicella Zoster Virus Infection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Herpesviridae Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Varicella Zoster Virus Infection →