Cell-mediated Immunity for Prevention of CMV Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

Group Type EXPERIMENTAL

T-Track® CMV assay

Intervention Type OTHER

Control

T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

Group Type OTHER

T-Track® CMV assay

Intervention Type OTHER

Interventions

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T-Track® CMV assay

Intervention Type OTHER

Other Intervention Names

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Quantiferon-CMV® assays Valganciclovir

Eligibility Criteria

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Inclusion Criteria

* 18 years old
* Kidney or liver transplantation
* Scheduled to receive CMV antiviral prophylaxis:
* CMV D+/R- patients
* Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)