Cell-mediated Immunity for Prevention of CMV Disease

Status Completed

Clinical Trial Summary

An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Patients will be randomized during the first month post transplant. In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis will depend on the result of the assay: - T-Track positive (patient at lower risk): discontinuation of the antiviral drug - T-Track negative (patient at higher risk): continuation of the antiviral drug until the maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of the interventional arm, but the result will not be known by the investigators. After discontinuation of prophylaxis, patients in both arms will be followed for the development of CMV replication at each visit using the local PCR assay and antiviral therapy will be administered in case of CMV infection according to local guidelines. The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV replication during the first 12 months post transplant AND the duration of antiviral prophylaxis.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02538172
Study type	Interventional
Source	University of Lausanne Hospitals
Contact
Status	Completed
Phase	N/A
Start date	October 2015
Completion date	January 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03950414` - A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients	Phase 1
Recruiting	`NCT04690933` - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Withdrawn	`NCT04936971` - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response	Phase 4
Recruiting	`NCT02671318` - Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence	Phase 4
Completed	`NCT01325636` - Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus	Phase 1/Phase 2
Recruiting	`NCT00228202` - Genotyping of Cytomegalovirus From Patients in Israel	N/A
Completed	`NCT00031421` - Neonatal CMV-Ganciclovir Follow-up Study	N/A
Completed	`NCT00005496` - Inflammation, Infection, and Future Cardiovascular Risk	N/A
Terminated	`NCT03262194` - Relevance of Gastric Aspirate in HCMV Detection
Completed	`NCT04478474` - Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
Recruiting	`NCT05370976` - Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation.	Phase 2
Active, not recruiting	`NCT02943057` - Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis	Phase 4
Completed	`NCT02642822` - The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University	N/A
Completed	`NCT02134184` - The Influence of Chronic CMV Infection on Influenza Vaccine Responses	Phase 4
Completed	`NCT00673868` - Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants	Phase 1
Active, not recruiting	`NCT05089630` - A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults	Phase 1/Phase 2
Not yet recruiting	`NCT06058858` - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Active, not recruiting	`NCT04904614` - Letermovir Use in Heart Transplant Recipients	Phase 4
Completed	`NCT01986010` - Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)	Phase 1
Recruiting	`NCT06145178` - A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants	Phase 1