HHV8 and Solid Organ Transplantation

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05081141
• Other study ID #: S_OTTO
• Status: Recruiting
• Start date: September 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Valeria Rossetti, MD
• Phone: 0039 2 55033782
• Email: valeria.rossetti[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castleman Disease
• Infections
• Kaposi Sarcoma
• Kidney Transplant; Complications
• Liver Transplant; Complications
• Lung Transplant; Complications
• Neoplasms
• Sarcoma
• Sarcoma, Kaposi

Intervention

Diagnostic Test:
• Diagnostic test for HHV8 exposure
Venipuncture for blood sampling

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Chiereghin A, Barozzi P, Petrisli E, Piccirilli G, Gabrielli L, Riva G, Potenza L, Cappelli G, De Ruvo N, Libri I, Maggiore U, Morelli MC, Potena L, Todeschini P, Gibertoni D, Labanti M, Sangiorgi G, La Manna G, Pinna AD, Luppi M, Lazzarotto T. Multicenter Prospective Study for Laboratory Diagnosis of HHV8 Infection in Solid Organ Donors and Transplant Recipients and Evaluation of the Clinical Impact After Transplantation. Transplantation. 2017 Aug;101(8):1935-1944. doi: 10.1097/TP.0000000000001740. — View Citation

Pietrosi G, Vizzini G, Pipitone L, Di Martino G, Minervini MI, Lo Iacono G, Conaldi PG, Grossi P, Lamonaca V, Galatioto L, Gruttadauria S, Gridelli B. Primary and reactivated HHV8 infection and disease after liver transplantation: a prospective study. Am J Transplant. 2011 Dec;11(12):2715-23. doi: 10.1111/j.1600-6143.2011.03769.x. Epub 2011 Oct 3. — View Citation

Polizzotto MN, Uldrick TS, Wyvill KM, Aleman K, Marshall V, Wang V, Whitby D, Pittaluga S, Jaffe ES, Millo C, Tosato G, Little RF, Steinberg SM, Sereti I, Yarchoan R. Clinical Features and Outcomes of Patients With Symptomatic Kaposi Sarcoma Herpesvirus (KSHV)-associated Inflammation: Prospective Characterization of KSHV Inflammatory Cytokine Syndrome (KICS). Clin Infect Dis. 2016 Mar 15;62(6):730-738. doi: 10.1093/cid/civ996. Epub 2015 Dec 12. Erratum In: Clin Infect Dis. 2018 Mar 5;66(6):985. — View Citation

Riva G, Luppi M, Barozzi P, Forghieri F, Potenza L. How I treat HHV8/KSHV-related diseases in posttransplant patients. Blood. 2012 Nov 15;120(20):4150-9. doi: 10.1182/blood-2012-04-421412. Epub 2012 Sep 11. — View Citation

Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HHV8 seropositivity among SOT donors and recipients	Incidence of HHV8 seropositivity among solid organ transplantations donors, candidates and recipients	2021-2024
Primary	Incidence of HHV8 mismatch between SOT donors and recipients	Incidence of HHV8 mismatch between solid organ transplantations donors and recipients	2021-2024
Secondary	Incidence of HHV8 related disease after solid organ transplantation	Incidence of HHV8 related disease after solid organ transplantation	2021-2025