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Cytomegalovirus Infections clinical trials

View clinical trials related to Cytomegalovirus Infections.

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NCT ID: NCT02600065 Completed - Clinical trials for Cytomegalovirus Infections

Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy

GLIO-CMV-01
Start date: November 2014
Phase:
Study type: Observational

Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.

NCT ID: NCT02594566 Withdrawn - Clinical trials for Congenital Cytomegalovirus Infection

Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine

CM04-101
Start date: November 2015
Phase: Phase 1
Study type: Interventional

If the participant decides to take part in the study, the participant will need to do the following: Visit the study clinic up to 10 times and be available for a reasonable amount of follow up phone calls to see how the participant is doing. The participant will receive three doses of vaccine injected into the muscle of the upper arm. After each injection the participant will be asked to remain at the study site for at least 30 minutes after the participant receives the study vaccine. The results of all of the participants blood tests, just like all other laboratory test results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV and viral hepatitis test results will be reportable to local health authorities according to local laws. The participant will be asked to refrain from excessive physical activities and alcohol consumption within 2 days before each clinic visit to avoid possible confusing effects on laboratory tests.

NCT ID: NCT02550639 Completed - Clinical trials for Kidney Transplantation

Prospective, Randomized Study for Predicting Human Cytomegalovirus (hCMV) Infection Based on Baseline hCMV Specific T-cell Response in Kidney Transplant

RESPECT
Start date: February 2014
Phase: Phase 4
Study type: Interventional

The aim of this prospective, randomized study is to assess a subject's immunological status against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT technique confirming previous results and establishing their statistical validity in order to determine whether this test could be used routinely in clinical practice to assess the risk of developing hCMV infection after renal transplantation and, ultimately, identify the most effective individual antiviral therapeutic strategy against hCMV.

NCT ID: NCT02538172 Completed - Clinical trials for Cytomegalovirus Infections

Cell-mediated Immunity for Prevention of CMV Disease

Start date: October 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02506933 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant

Start date: November 5, 2015
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.

NCT ID: NCT02456610 Recruiting - Viral Infection Clinical Trials

Administration of Virus Specific CTLs for the Prophylaxis and Treatment of EBV/CMV Infections After HSCT in China

Start date: May 2015
Phase: Phase 1
Study type: Interventional

Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given either prophylactically or as early therapy for patients with detectable viral loads appear to be an effective strategy for reducing viral infections. However, long-term treatment with these drugs is associated with significant toxicity, expense and the appearance of drug resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T cells infusion to immunocompromised patients following HSCT is able to induce a successful anti-viral response. The primary purpose of this study is to determine the safety and efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with CMV and EBV reactivation or infection.

NCT ID: NCT02454699 Completed - Clinical trials for Cytomegalovirus Infection

Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers

Start date: November 10, 2015
Phase: Phase 1
Study type: Interventional

This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed. Subjects must be 18 to 65 years of age, male or female; if female, be surgically-sterilized or post-menopausal; if male, have undergone vasectomy; have a body mass index (BMI) of 18 to 32 kg/m^2; not be a user of nicotine-containing products; be willing to abstain from nicotine-containing products, alcohol and illicit drugs during the study. Subjects will be followed for 28 days post dosing.

NCT ID: NCT02439970 Terminated - Clinical trials for Cytomegalovirus Disease

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease

SUSTAIN
Start date: September 2015
Phase: Phase 3
Study type: Interventional

To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor

NCT ID: NCT02439957 Terminated - Clinical trials for Kidney Transplant Infection

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

Start date: September 2015
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy.

NCT ID: NCT02439372 Completed - Ulcerative Colitis Clinical Trials

Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis

ACE-UC
Start date: April 2015
Phase:
Study type: Observational

Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.