Herpesviridae InfectionsNCT05198570
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
An observational study of Herpesviridae Infections and Herpes Simplex 1, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection
- What is being tested?
- Pharmacokinetic analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2021to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- lack of signed informed consent
- lack of TDM for ACV
- unavailable patient's demographic characteristics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health
Trieste, TS, 34137
Natalia Maximova, MD, natalia.maximova@burlo.trieste.it
Antonello Di Paolo, MD
About this study
Official title: Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
- 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.
Read the detailed description
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.
- Conditions
- Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection, Transplantation Infection, Oncology
- Being tested
- Pharmacokinetic analysis
- Keywords
- Hematopoietic stem cell transplantation, Herpes virus infections, Aciclovir, Children, Pharmacokinetics
- Medical subject headings
- Herpesviridae Infections, Varicella Zoster Virus Infection, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic analysisOther
Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Aciclovir | Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections Receives: Other: Pharmacokinetic analysis | |
| Oral Aciclovir | Patients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections Receives: Other: Pharmacokinetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months since the beginning of acyclovir administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start15 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpesviridae InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Burlo Garofolo
- Responsible party
- Principal investigator, Antonello Di Paolo, M.D., Ph.D., University of Pisa
- Investigators
- Natalia Maximova, MD, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198570
- Sponsor's protocol ID
- RC_10/20
- Status last verified
- Jun 2025
- First submitted
- 4 Jan 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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.
PubMed 35496277
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
- ClinicalTrials.gov ID
- NCT05198570
- Acronym / sponsor ID
- RC_10/20
- Conditions
- Herpesviridae Infections, Herpes Simplex 1, Varicella Zoster Virus Infection, Transplantation Infection, Oncology
- Keywords
- Hematopoietic stem cell transplantation, Herpes virus infections, Aciclovir, Children, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- IRCCS Burlo Garofolo
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Aciclovir | – | Other: Pharmacokinetic analysisPatients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections |
| Oral Aciclovir | – | Other: Pharmacokinetic analysisPatients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- lack of signed informed consent
- lack of TDM for ACV
- unavailable patient's demographic characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic analysisPopulation pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring | Other | Intravenous Aciclovir, Oral Aciclovir |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 35496277Maximova 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalia Maximova, MD principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpesviridae Infections and Herpes Simplex 1, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Maximova, MD (040 378 5111 ext. 565, natalia-maximova@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.