HHV8 and Solid Organ Transplantation

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

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

Treatments: Diagnostic Test: Diagnostic test for HHV8 exposure

Study type: Observational

Funder types: Other

Identifiers

NCT05081141

S_OTTO

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Exclusion Criteria:

• None

Trial design

250 participants in 4 patient groups

SOT Donors

Description:

Solid organ transplantation donors

Treatment:

Diagnostic Test: Diagnostic test for HHV8 exposure

LuTx candidates and recipients

Description:

Lung transplant candidates and recipients

Treatment:

Diagnostic Test: Diagnostic test for HHV8 exposure

LTx candidates and recipients

Description:

Liver transplant candidates and recipients

Treatment:

Diagnostic Test: Diagnostic test for HHV8 exposure

KTx candidates and recipients

Description:

Kidney transplant candidates and recipients

Treatment:

Diagnostic Test: Diagnostic test for HHV8 exposure