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Showing 1-14 of 14 trials
NCT06853184
This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.
NCT03798301
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections. The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). Participants will be followed for one year.
NCT06362720
The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are: * How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen? * progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT * The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM * Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record.
NCT02680743
Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric hearing loss and an important cause of neurodevelopmental delay. Symptomatic infants are readily identified and quickly referred for treatment, but the majority of infants (85-90%) with cCMV show no symptoms at birth and therefore do not receive timely treatment. Often, these otherwise asymptomatic infants with cCMV may have early congenital hearing loss and therefore fail the newborn hearing screen, but because they are not specifically identified as having cCMV there is a delay in seeking further audiology exam and treatment of the CMV infection. This study will investigate how testing newborns for congenital cytomegalovirus infection (cCMV) after a failed newborn hearing screens can improve early identification of cCMV infection and therefore reduce the delay in referral of the newborn to appropriate specialists for intervention.
NCT06021210
Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS
NCT05914675
To evaluate the efficacy and safety of primary prophylaxis of CMV reactivation, clinically significant CMV infection with oral letermovir in Chinese R+ haplo-HSCT patients, as well as treatment-related mortality and all-cause mortality within 24 weeks after transplantation. For enrolled patients, Letermovir would be administered at a dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine). The regimen would start between +7\~+14d after transplantation. The total duration of dosing was approximately 100 days or 14 weeks.
NCT05140187
This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after allogenic HSCT.
NCT02985775
Cytomegalovirus (CMV) infections remain an important cause of morbidity and mortality in allogeneic hematopoietic cell transplant (HSCT) recipients, especially in patients received haploidentical transplantation. During the past decades, prophylactic or preemptive treatment with antiviral drugs has significantly reduce the incidence of early-onset CMV infection. Unfortunately, prolonged antiviral treatment is associated with substantial toxicity and may delay recovery of virus specific immune responses, resulting in an increasing of late-onset CMV disease. To date, adoptive immunotherapies have been developed as treatment alternatives to antiviral agents for CMV infection after HSCT. Studies have demonstrated that prophylactic or preemptive therapy with donor CMV-specific T cells can restore antiviral immunity and clear CMV viremia after transplantation. In this prospective clinical phase I/II trial, we propose to reconstitute antiviral immunity against CMV by preemptive transfer of CMV-specific T cells at an early time point after allogeneic stem cell transplantation. We also propose to demonstrate whether protect against CMV is associated with recovery of CMV-specific T cells.
NCT03159364
Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients. HSCT patients often face opportunistic infections due to the immunosuppressive state during transplantation. Antimicrobial drugs are usually used for prophylactic purposes and for treatment after early detectable infections. Unfortunately, some patients develop resistance to such drug treatment. In addition to HSCT patient, immune compromised patient may also be victim to opportunistic infections. Many infections can be effectively managed by functional immune recovery. In this study, the safety and efficacy of microbial-specific cytotoxic T lymphocytes (CTLs) will be investigated.
NCT02313857
Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. CMV can cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Investigators want to see if they can use a kind of white blood cell called T cells to treat CMV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated CMV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target CMV. In this study, investigators want to find out if the banked CMV-specific T cells derived from healthy donors are safe and can help to treat CMV infection. The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food and Drug Administration (FDA).
NCT03369912
The purpose of the study is to evaluate the feasibility of using CSJ148 to prevent congenital human cytomegalovirus (HCMV) in pregnant women with primary HCMV infection.
NCT01633476
The purpose of this study is to determine whether Cytomegalovirus (CMV) reactivation in ANCA-associated vasculitis (AAV) patients can be effectively and safely reduced using an antiviral agent (valaciclovir) and whether this in turn improves the function of the immune system thereby also improving the body's ability to fight other infections. The primary hypothesis is that repeated episodes of CMV reactivation in AAV patients drive the expansion and functional impairment of CMV-specific T-cells, with increased susceptibility to infection. Inhibition of CMV replication with valaciclovir will block further stimulation of CMV specific T-cells and increase the functional capacity of the immune system.
NCT02324244
Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a broad cohort of consecutive immunocompetent adults admitted to a major heart surgery intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors, and clinical significance of CMV infection.
NCT00168259
The study is designed to evaluate interferon responses to CMV in HIV positive individuals and a component will look at interferon responses to CMV in HIV positive individuals over time after commencement of antiretroviral therapy. We will also look at the correlation between CD4 T cell numbers and HLA type with the interferon response.