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HHV8 and Solid Organ Transplantation

Screening for HHV8 Infection in Solid Organ Transplantation Donors, Candidates and Recipients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05081141
Enrollment
250
Registered
2021-10-18
Start date
2021-09-15
Completion date
2025-12-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castleman Disease, HHV8, HHV8 Infection, HHV8-Related Malignant Neoplasm, Kaposi Sarcoma, Kidney Transplant; Complications, Liver Transplant; Complications, Lung Transplant; Complications

Keywords

HHV8, Solid organ transplant, Lung transplant, Liver transplant, Kidney transplant, Kaposi Sarcoma, Castleman Disease

Brief summary

Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation. In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.

Detailed description

Patients on the waiting list for solid organ transplantation will undergo serological screening for HHV8 (lytic and latent antigens) in the pre-transplant phase, both at time of listing and then at the time of transplantation; if seropositivity is found, further investigations will be performed, i.e. blood levels of HHV8 DNA and specific Elispot for HHV8. As for donors, serological testing for HHV8 (lytic and latent antigens) will be performed. AFTER SOLID ORGAN TRANSPLANTATION * Patients found HHV8 seropositive in the pretransplant phase (R +), being at risk of HHV8 reactivation, will be monitored monthly in terms of viremia (HHV8 DNA) and specific IGRA for HHV8 for the first 6 months after transplantation and subsequently every 3 months up to 12 months post transplant. * In case of patients who were found HHV8 seronegative at time of transplantation, donor serology will be evaluated. In case of R-/D+ mismatch, SOT recipients will receive the same monitoring of R + patients (blood levels of HHV8 DNA and specific IGRA for HHV8 monthly for the first 6 months and then every 3 months up to 12 months after transplantation). * With reference to lung transplant patients, in cases of R + or R- / D +, HHV8 DNA will also be searched on the BAL obtained during surveillance bronchoscopies (usually at 3, 6 and 12 months after transplantation).

Interventions

DIAGNOSTIC_TESTDiagnostic test for HHV8 exposure

Venipuncture for blood sampling

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

SOT DONORS: Inclusion Criteria: * all donors used for transplantation purposes (kidney, liver, lung), including living donors in case of kidney transplantation

Exclusion criteria

* None SOT CANDIDATES RECIPIENTS: Inclusion Criteria: * All patients listed for solid organ transplantation (lung, liver and kidney)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of HHV8 seropositivity among SOT donors and recipients2021-2024Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients
Incidence of HHV8 mismatch between SOT donors and recipients2021-2024Incidence of HHV8 mismatch between solid organ transplantations donors and recipients

Secondary

MeasureTime frameDescription
Incidence of HHV8 related disease after solid organ transplantation2021-2025Incidence of HHV8 related disease after solid organ transplantation

Countries

Italy

Contacts

Primary ContactValeria Rossetti, MD
valeria.rossetti@policlinico.mi.it0039 2 55033782
Backup ContactLetizia Corinna Morlacchi, MD
letizia.morlacchi@policlinico.mi.it0039 2 55033782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026