[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cmv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cmv":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,53,89,123,149,174,196,222,249,275,297,319],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":4,"leadSponsor":49,"locationsCount":52},"100133849","the-natural-history-of-severe-viral-infections-and-characterization-of-immune-defects-in-patients-without-known-immunocompromise-100133849",false,"NCT01011712","The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise","The Natural History of Severe Viral Infections and Characterization of Immune Defects","* INCLUSION CRITERIA:\n\n(Participants)\n\nParticipants must meet all the following inclusion criteria in order to participate in this study:\n\n1. Children or adults (regardless of age) with a definitively diagnosed severe or unusual viral infection, including but not limited to infections caused by herpesviruses (HSV-1, HSV-2, CMV, EBV, VZV, HHV-6, HHV-7, HHV-8), human papillomavirus (e.g., severe recalcitrant warts), adenovirus, calicivirus (e.g. norovirus), polyomavirus (such as JC virus and BK virus), or influenza virus. Viral infections that would be considered opportunistic-like , such as herpesvirus esophagitis, herpesvirus encephalitis, CMV colitis, or progressive multifocal leukoencephalopathy (caused by the JC polyoma virus) will be of particular interest in this protocol.\n\n   OR\n\n   Children or adults with a well-documented prior, severe, persistent, or treatment-refractory viral infection(s), who have clinically recovered from the viral infection.\n2. Ongoing care by a referring physician.\n3. Willingness to allow storage of blood and tissue samples for future analyses.\n\n(Relatives)\n\nRelatives (2 years or above) may be recruited and enrolled to improve interpretation of genetic results, to expand the phenotype of the suspected or confirmed inborn error of immunity in the proband with severe viral infection, and to understand the co-factors in affected and\u002For unaffected family members that may influence variable expressivity and penetrance of viral infections in inborn errors of immunity.\n\n1. Males and females will be accepted.\n2. Relatives may either be healthy or have features concerning for an inborn error of immunity including, but not limited to, autoimmunity, severe atopy, other forms of immune-dysregulation, or severe or unusual infections. While the enrolled proband must have a current or prior severe or unusual viral infection, family members who are suspected to have an inborn error of immunity do not need to have a history of severe or unusual viral infection in the presence of other features suspicious for inborn errors of immunity.\n3. Adult relatives or the guardians of minor relatives must be willing and capable of providing informed consent after review of protocol procedures that are described in the consent form with an appropriate study team member.\n4. Participating relatives agree to have blood stored for future studies of the immune system.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following exclusion criteria at baseline will be excluded from study participation:\n\n1. Patients with previously diagnosed conditions associated with acquired or iatrogenic immunodeficiency and\u002For immunosuppresion (e.g., a history of HIV infection, a positive test for HIV, chemotherapy or high dose glucocorticoids). Patients on immunosuppression and\u002For immunomodulatory therapy for the treatment of conditions that may be attributable to an underlying inborn error of immunity may be included in the study at the discretion of the PI or their designee.\n2. Women who are pregnant.\n3. Any condition or major comorbidity that the study investigators believe will compromise the patient's ability to comply with the requirements of the study.","ALL","2 Years","100 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","Background:\n\n* Infections caused by viruses are common causes of illnesses: the common cold, many ear infections, sore throats, chicken pox, and the flu are caused by different viruses. Usually, these illnesses last only few days or, at most, a few weeks. Some virus infections like influenza are cleared from the body, and others such as the chicken pox virus remain in the body in an inactive state. However, some people may become quite ill when they are infected with a particular virus, possibly because part of their immune system does not respond properly to fight the virus.\n* Researchers have discovered some reasons why a person may not be able to clear an infection caused by a virus. Some persons have changes in the genes that involve the immune system that result in the inability to properly control infection with a particular virus. Identifying changes in genes that involve the immune system should help scientists better understand how the immune system works to protect people from infection and may help develop new therapies.\n\nObjectives:\n\n* To study possible immune defects that may be linked to a particular severe viral infection.\n* To determine if identified immune defects are genetic in origin.\n\nEligibility:\n\n* Individuals of any age who have or have had a diagnosis of a virus infection that physicians consider to be unusually severe, prolonged, or difficult to treat.\n* Relatives of the participants with a severe viral infection may also participate in the study. We will use their blood and\u002For skin specimens to try to determine if identified immune defects are hereditary.\n\nDesign:\n\n* Prior to the study, the participant's doctor will give researchers the details of the infection, along with medical records for review. Eligible participants will be invited to the NIH Clinical Center for a full evaluation as an outpatient or inpatient.\n* At the Clinical Center, participants will be treated with the best available therapy for the particular viral infection, and researchers will monitor how the infection responds to the treatment.\n* Researchers will take intermittent blood samples and conduct other tests (such as skin biopsies) to evaluate the immune system. - During and after the illness, researchers will conduct follow-up visits to determine the course of infection and response to therapy.",[25,26,27,28,29],"EBV","HSV","VZV","HPV","CMV",[31,32,33,34,35,36,37,38,39,40,41],"Genetics","Virus","Defense","Immunity","Immunodeficiency","Natural History","Respiratory Viruses","Herpesvirus","Cytomegalovirus","Human Papillomavirus","Adenovirus","RECRUITING","2026-06-17",{"date":45,"type":46},"2026-06-18","ACTUAL",{"date":48,"type":46},"2009-10-01",{"name":50,"class":51},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":52},"100636857","phase-4-letermovir-vs-valganciclovir-in-cmv-r-kidney-transplant-100636857","NCT07571135","Letermovir vs Valganciclovir in CMV R+ Kidney Transplant","Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.","Inclusion Criteria (both arms):\n\n* ≥18 years old\n* Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant\n\nInclusion Criteria (letermovir arm):\n\n* Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation\n* Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation\n\nExclusion Criteria (both arms):\n\n* Multiorgan organ transplant\n* Received previous solid organ transplant or HSCT\n* Unable to take oral medications\n* Uncontrolled infections at the time of enrollment\n* Hemodynamically unstable or on mechanical ventilation at the time of enrollment\n* Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor\n* Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation\n* Received any anti-CMV drug treatment within 7 days prior to enrollment\n* Current user of recreational or illicit drugs or alcohol dependence\n* History of CMV disease prior to enrollment\n\nExclusion Criteria (letermovir arm):\n\n* Previously participated in a letermovir study or any other study with CMV investigational agents\n* On dialysis or plasmapheresis at the time of enrollment\n* Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations\n* Child-Pugh Class C severe hepatic insufficiency\n* Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study\n* Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine","18 Years",{"count":62,"type":21},300,"INTERVENTIONAL",[65],"PHASE4","The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir (\"mini dose\"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.\n\nThe main question the study wants to answer is:\n\n• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?\n\nThe study will also look at other important questions:\n\n* Is letermovir easier for patients to tolerate than valganciclovir?\n* How long does it take for a CMV infection to appear in each group?\n* Are there differences in \"breakthrough\" CMV infections between the two medications?\n* For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups",[68,29,69,70],"CMV Infection","CMV Viremia","CMV Disease",[29,72,73,74,75,76,77],"Kidney Transplant","Letermovir","Moderate Risk","CMV Prophylaxis","Valganciclovir","Neutropenia","NOT_YET_RECRUITING","2026-05-06",{"date":81,"type":46},"2026-05-08",{"date":83,"type":21},"2026-05",{"date":85,"type":21},"2028-11",{"name":87,"class":88},"Elisabeth Kincaide","OTHER_GOV",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100623204","id-entity-trial--evaluating-serial-t-id-monitoring-100623204","NCT07393594","ID-ENTITY Trial- Evaluating Serial T-ID Monitoring","A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation","ID-ENTITY","Inclusion Criteria:\n\n* Participants must meet all the following criteria:\n\n  * Written informed consent and HIPAA authorization obtained prior to any study-related data collection.\n  * Age ≥18 years at the time of enrollment.\n  * Recipient of a kidney transplant, including:\n  * Primary or repeat kidney transplantation\n  * Living-donor or deceased-donor transplantation\n  * At 1 month post-kidney transplant at the time of enrollment.\n  * Receiving maintenance immunosuppressive therapy per institutional standard of care.\n  * Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.\n\nExclusion Criteria:\n\n* Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and\u002For islet cell transplantation.\n* History of prior non-renal solid organ transplantation or islet cell transplantation.\n* Known pregnancy at the time of enrollment.\n* Known active viral infection at enrollment with any of the following:\n* Hepatitis B surface antigen (HBsAg)-positive\n* Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive\n* Human immunodeficiency virus (HIV) infection or HIV NAT-positive\n* \\*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.\n* Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures.\n* Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.\n\n  * Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.",{"count":98,"type":21},1000,"To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and\u002For biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).",[101,102,103,29,104],"Kidney Diseases","Kidney Injury","BK Virus Infection","TTV Virus",[106,107,108,109,110,111,112],"Biomarkers testing","Kidney transplant rejection","T-ID Assay","TRAC Assay cell free DNA","Biopsy","dd-cfDNA","T-ID","2026-02-20",{"date":115,"type":46},"2026-02-24",{"date":117,"type":21},"2026-03-31",{"date":119,"type":21},"2028-10-30",{"name":121,"class":122},"Transplant Genomics, Inc.","INDUSTRY",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":63,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":52},"100611061","phase-4-combination-letermovir-and-standard-of-care-antiviral-for-enhanced-antiviral-response-in-cytomegalovirus-infection-in-lung-transplant-recipients-100611061","NCT07235683","Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients","Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients: A Pilot Trial","CLEAR-CMV","Inclusion Criteria:\n\n* Recipient of a lung transplant.\n* Has confirmed CMV viremia with a viral load ≥ 1000 IU\u002FmL and will receive or has just started SOC antiviral treatment in the past 72h as per the decision of the treating physician.\n\nExclusion Criteria:\n\n* Renal failure with Creatinine clearance \\\u003C15 mL\u002Fmin or requiring dialysis\n* Severe hepatic impairment (Child-Pugh Class C)\n* Participating in another interventional clinical trial\n* Combined transplant (e.g heart-lung, lung-liver)\n* Known allergy or contraindication to any of the antiviral medications\n* Known antiviral resistance.\n* Patient receiving cyclosporin, pimozide or ergot alkaloids (due to significant drug interaction with letermovir).\n* Patient receiving or expected to receive CMV immunoglobulin or IVIG during the initial three week treatment phase",{"count":132,"type":21},40,[65],"The primary objective of the CLEAR-CMV trial is to evaluate the efficacy of letermovir therapy plus standard of care (SOC) antiviral compared to SOC plus placebo in achieving clearance of CMV viremia by week 3 in lung transplant recipients with active CMV infection.",[29,136],"Lung Transplant Recipient",[70,138],"Lung Transplant","2026-02-12",{"date":141,"type":46},"2026-02-17",{"date":143,"type":46},"2025-12-24",{"date":145,"type":21},"2027-08",{"name":147,"class":148},"University Health Network, Toronto","OTHER",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":63,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":52},"100578538","efficacy-of-extended-letermovir-prophylaxis-to-prevent-cmv-reactivation-in-high-risk-chinese-adults-undergoing-allogeneic-hsct-100578538","NCT06812598","Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT","A Clinical Study on the Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. The patients are ≥18 years old.\n3. The patients are CMV seropositive prior to transplantation.\n4. The patients have at least one high-risk factor for CMV reactivation, including:\n\n(1) Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation.\n\n(2) The primary source of stem cells is cord blood. (3) A conditioning regimen including total body irradiation (TBI). (4) A GVHD prophylaxis regimen containing alemtuzumab or high-dose anti-thymocyte globulin (ATG).\n\n5\\. The patients are able to comply with the study visit schedule, understand and agree to adhere to all protocol requirements, and have voluntarily signed the informed consent form to participate in the study.\n\n6\\. The patients have no plans for reproduction from the date of consent until 90 days after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. Patients with evidence of CMV viremia at any time prior to enrollment.\n3. Patients with a history of CMV end-organ disease within 6 months prior to enrollment.\n4. Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs.\n5. Patients with severe hepatic impairment (defined as Child-Pugh Class C).\n6. Patients with end-stage renal disease with a creatinine clearance \\\u003C 10 mL\u002Fmin.\n7. Patients requiring mechanical ventilation or experiencing hemodynamic instability at the time of enrollment.\n8. Patients who received any investigational drug therapy within 28 days prior to enrollment.\n9. Patients who received or plan to receive any of the following treatments within 28 days prior to enrollment or during the study: cidofovir, CMV immune globulin, or any experimental CMV antiviral drugs\u002Fbiological therapies.\n10. Patients who previously participated or are currently participating in any study involving a CMV vaccine or other CMV investigational drugs, or who plan to participate in such studies during this trial.\n11. Patients who are pregnant or breastfeeding at the time of enrollment or planning to become pregnant within 90 days after the last dose of study medication.\n12. Patients who test positive for human immunodeficiency virus antibodies (HIV-Ab) at any time prior to randomization, or who test positive for hepatitis C virus antibodies (HCV-Ab) with detectable HCV RNA, or for hepatitis B surface antigen (HBsAg) within 90 days prior to randomization. Laboratory testing for HIV, HBV, or HCV is allowed using locally acceptable methods.\n13. Patients with active solid malignancies, except for localized basal cell or squamous cell carcinoma of the skin or a condition currently under treatment (e.g., lymphoma).",{"count":157,"type":21},330,[159],"NA","After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. International clinical guidelines for the management of CMV infection post-allo-HSCT recommend three main strategies: minimizing infection risk, prevention, and preemptive therapy. However, traditional antiviral agents have not been approved for CMV prophylaxis in allo-HSCT recipients and are associated with significant adverse effects and the development of resistance, leaving the CMV prevention needs of this patient population unmet. Recent studies have demonstrated that letermovir prevents potent and highly specific antiviral activity against CMV, and it has been approved for CMV prophylaxis within the first 100 days post-allo-HSCT. Furthermore, evidence suggests that extending letermovir administration up to 28 weeks further reduces the risk of CMV infection in the later post-transplant period without increasing drug-related mortality. In China, the post-allo-HSCT CMV prevention strategy faces challenges such as limited treatment options, unclear guideline recommendations, non-standardized drug usage in certain medical institutions, and insufficient monitoring. This study aims to provide robust, evidence-based support for the use of letermovir in high-risk CMV reactivation among adult allo-HSCT recipients, thereby broadening clinical treatment choices.",[162,29],"Cytomegalovirus Infections",[73,164],"Allogeneic Hematopoietic Stem Cell Transplantation","2026-01-19",{"date":167,"type":46},"2026-01-21",{"date":169,"type":46},"2024-12-16",{"date":171,"type":21},"2026-12-31",{"name":173,"class":148},"The First Affiliated Hospital of Soochow University",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":52},"100614966","viromarkers-ga-n101194735---cmv-and-ttv-biomarkers-study-protocol-100614966","NCT07286461","VIROMARKERS GA n.101194735 - CMV and TTV Biomarkers Study Protocol","Inclusion Criteria:\n\n* Be \\> 18 years of age\n* Sign an informed consent\n* HSCT recipients seropositive to CMV, or receiving HSCs from a CMV seropositive donor\n* Antiviral prophylaxis with letermovir for preventing CMV infection will be administered for 100 days in Italy (or 200 days in Germany) after HSCT to all participants according to the current guidelines\n\nExclusion Criteria:\n\nIndividuals \\\u003C18 years old undergoing HSCT Individuals not receiving letermovir prophylaxis",{"count":181,"type":21},290,"The study is one of the researches carried out in the VIROMARKERS Project.\n\nThe project VIROMARKERS is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101194735. The JU receives support from the European Union's Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bio, MedTech Europe, Vaccines Europe, and Roboscreen.\n\nTo date, the virological surveillance for CMV replication relies basically on the quantification of CMV-DNA in blood or plasma by using Real-Time PCR assays, and CMV-DNAemia is known to correlate with both CMV-related disease and non-relapse mortality \\[Ljungman, 2025\\]. However, the detection of CMV-DNAemia is not always associated with an active CMV replication, particularly in patients exposed to letermovir. Therefore, the identification of new virological markers to accurately monitor CMV activity in the early and late post-HSCT phases, remains a crucial issue especially in individuals receiving letermovir as prophylaxis to ensure a proper diagnosis of CMV infection\u002Fdisease and to guide prophylactic and pre-emptive antiviral treatment.\n\nIn this setting, the quantification of CMV-RNA represents a potential candidate marker capable of better reflecting the presence of complete, infectious CMV virions than CMV-DNAemia. Despite several data support a correlation of CMV UL21.5-mRNA with viral activity \\[Nicastro, 2025\\], studies investigating the kinetics of this viral mRNA among immune-suppressed patients at risk of CMV re-uptake are largely missing, especially in the setting of patients receiving antiviral prophylaxis with letermovir after HSCT.\n\nTTV-DNA load was mostly investigated in solid organ transplant patients (SOT), where it showed a good correlation of high viral load and degree of immunosuppression. In HSCT patients the interaction of the immune system, which is under reconstitution, and clinically relevant CMV infection is more complex. First data have been reported by our group \\[Gilles et al., 2017\\] showing high TTV load as a prognostic marker for risk of complications after HSCT. Little information is available for HSCT patients under letermovir prophylaxis.\n\nSpecific primary objectives related to CMV monitoring in the HSCT setting are the following:\n\nPrimary In participants who received HSCT, to estimate the rate of initiation of anti-CMV therapy during letermovir-based prophylaxis and the rate of CMV re-activation (based on symptoms, signs of organ dysfunction and CMV-DNAemia) after suspension of letermovir.\n\nTo evaluate the kinetics of CMV-RNAemia, CMV-DNAemia and TTV-DNAemia and their correlation during prophylaxis with letermovir.\n\nTo establish whether early quantitative CMV-RNA level or the early kinetics of CMV-RNAemia and TTV-DNAemia during prophylaxis can predict initiation of anti-CMV therapy.\n\nIn participants not initiating anti-CMV therapy during prophylaxis, to establish whether quantitative CMV-RNA level at time of letermovir suspension or the kinetics of CMV-RNAemia and TTV-DNAemia during prophylaxis can predict CMV re-activation (based on symptoms signs of organ dysfunction and CMV-DNAemia) after suspension of letermovir.\n\nSecondary objectives include to establish a cut-off for CMV-RNAemia and TTV DNAemia to maximize the accuracy of prediction of CMV re-activation after suspension of prophylaxis; to explore the kinetics of CMV-RNAemia and TTV-DNAemia in participants treated with anti CMV drugs.\n\nThe information used from this study on participants in the HSCT setting will be rapidly analyzed and shared broadly to guide policymakers for the use and monitoring of CMV-DNAemia, CMV-RNAemia and TTV-DNAemia in CMV disease and to design future studies. For exact plans regarding the expected date of study completion and plans for dissemination please refer to separate documents produced within the WP5 of VIROMARKERS.",[184,29],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient",[29,186],"TTV","2025-12-02",{"date":189,"type":46},"2025-12-16",{"date":191,"type":21},"2025-12-15",{"date":193,"type":21},"2027-12-30",{"name":195,"class":148},"University of Rome Tor Vergata",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":63,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":4},"100610314","phase-3-phase-3-randomized-trial-for-refractory-adv-or-cmv-infection-with-family-matched-ctls-and-standard-of-care-soc-vs-soc-alone-100610314","NCT07225972","Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone","An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection\u002FViremia","Patient Eligibility Cohort 1 (ADV) -Patients with ADV infections (Cohort 1) (pneumonitis, hepatitis, cystitis, and\u002For colitis) post AlloHSCT with one or more of the following: Increasing or persistent ADV RT-PCR DNA (\\> 1000 ADV PCR copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-viral therapies including one or more of the following: \\> grade 2 renal insufficiency secondary to cidofovir and\u002For other \\> grade 2 toxicities secondary to cidofovir AND\u002FOR Known resistance to cidofovir\n\nPatient Eligibility (Cohort 2) (CMV)\n\n-Patients with CMV infections (pneumonitis, hepatitis, colitis) with one or more of the following: Increasing or persistent CMV RT-PCR DNA (\\>1000 copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-CMV antibiotic therapies: ANC \\> 500\u002Fmm3 secondary to ganciclovir AND\u002FOR \\> grade 2 renal toxicity secondary to either foscarnet or cidofovir AND\u002FOR Known resistance to ganciclovir and\u002For foscarnet\n\n* Consent: written informed consent given (by patient or legal representative) prior to any study related procedures\n* Performance Status \\>30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 years (BOTH COHORTS)\n* Age: 0.01 to 30.00 years (BOTH COHORTS)\n* Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS)\n\nDonor Eligibility\n\n* Related donor available with a T-cell response to the ADV MACS PepTivators (Cohort 1) or CMV MACS PepTivator (Cohort 2). As defined in Appendix II, B, 8.2, the donor is considered suitable if the percentage of IFN+ T-cells is \\>0.01% after stimulation with ADV PepTivators (Cohort 1) or CMV PepTivators (Cohort 2).\n* Third-party related allogeneic donor: If original donor is not available or does not have a T-cell response to ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2), third party allogeneic donor (family donor \\> 3 HLA A, B, DR match to recipient) with a T-cell response at least to the ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2) AND\n* Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1) AND\n* Obtained informed consents by donor or donor legally authorized representative prior to donor collection\n\nPatient Exclusion Criteria (Both Cohorts)\n\n* Patient with acute GVHD \\> grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion.\n* Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CTL infusion.\n* Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion.\n* Patient with poor performance status determined by Karnofksy (patients \\> 16 yrs) or Lansky (patients \\\u003C 16 years) score \\\u003C 30%.\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ADV or CMV infections.\n* Any known medical condition which cold compromise participation in the study according to investigators assessment.\n* Known AIDS or uncontrolled HIV infection\n* Known hypersensitivity to iron dextran\n* Encephalitis and\u002For retinitis","1 Day","30 Years",{"count":206,"type":21},69,[208],"PHASE3","Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.",[29,211,212,41,162],"AdV Infection","AdV Reactivation","2025-11-06",{"date":215,"type":46},"2025-11-10",{"date":217,"type":21},"2026-12-01",{"date":219,"type":21},"2032-12-01",{"name":221,"class":148},"New York Medical College",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":63,"phases":232,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":247,"locationsCount":52},"100600358","phase-1-cmvig-prophylaxis-in-belatacept-conversion-kidney-transplant-recipients-100600358","NCT07096453","CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients","CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study","Inclusion Criteria:\n\n* Adult (18-70 year old) kidney transplant recipients\n* Patients transitioning from conventional CNI-based immunosuppression to co-stimulatory blockade (belatacept) immunosuppression OR patients who are stable on belatacept immunosuppression at the time of initial CYTOGAM infusion\n* CMV Ig Seronegative Recipient who received a CMV Ig seropositive Donor\n* EBV IgG Positive\n\nExclusion Criteria:\n\n* Pregnant people\n* Subjects unwilling to sign consent and complete follow up visits\n* Subjects with IgA immunodeficiency\n* Subjects who are receiving IgG therapy or who have received IgG therapy within two months of study enrollment\n* Patients who do not speak English and would need a translator and translated consent materials in order to obtain informed consent","70 Years",{"count":231,"type":21},30,[233,234],"PHASE1","PHASE2","The purpose of this study is to study how CMVIG interacts with the body and to see if it might work to prevent kidney transplant patients from becoming infected with CMV.",[237,29],"Kidney Transplant; Complications",[239,240],"Kidney transplant","CMV prevention","2025-10-29",{"date":243,"type":46},"2025-10-31",{"date":245,"type":46},"2025-10-02",{"date":145,"type":21},{"name":248,"class":148},"University of Minnesota",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":63,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":52},"100550928","phase-2-cmv-tcip-directed-letermovir-prophylaxis-after-allo-sct-100550928","NCT06453460","CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT","Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* ≥ 18 years of age on the day of signing informed consent.\n* Karnofsky performance \\>70%\n* Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.\n* Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.\n* Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.\n* Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.\n* Be able to comply with medical recommendations or follow-up.\n* Has adequate organ functions determined by\n\n  1. Serum creatinine clearance ≥50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n  2. Bilirubin ≤1.5 mg\u002Fdl except for Gilbert's disease.\n  3. ALT or AST ≤200 IU\u002Fml for adults.\n  4. Conjugated (direct) bilirubin \\\u003C 2x upper limit of normal.\n  5. Left ventricular ejection fraction ≥40%.\n  6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.\n\nExclusion Criteria:\n\n* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.\n* Received within 7 days prior to screening or plans to receive during the study any of the following:\n\n  1. Ganciclovir\n  2. Valganciclovir\n  3. Foscarnet\n  4. Acyclovir (\\> 3200 mg PO per day or \\> 25 mg\u002Fkg IV per day)\n  5. Valacyclovir (\\> 3000 mg\u002Fday)\n  6. Famciclovir (\\> 1500 mg\u002Fday)\n* Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent\u002Fbiologic therapy.\n* Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.\n* Has an uncontrolled infection\n* Requires mechanical ventilation or is hemodynamically unstable",{"count":257,"type":21},50,[234],"This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.",[29,261],"Allogeneic Stem Cell Transplantation",[263,264,265,73],"CMV T Cell Immunity Panel","CMV reactivation","Allogeneic stem cell transplantation","2025-07-03",{"date":268,"type":46},"2025-07-09",{"date":270,"type":46},"2024-06-27",{"date":272,"type":21},"2029-06",{"name":274,"class":148},"University of California, Irvine",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":63,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":52},"100590783","phase-2-efficacy-and-safety-of-low-dose-il-2-in-sle-patients-with-cmv-viremia-100590783","NCT06971913","Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia","Inclusion Criteria:\n\n* Meet the American College of Rheumatology criteria for the diagnosis of SLE.\n* The test for plasma CMV DNA viral load is positive.\n* Age: 18 to 65 years, weight 45-80kg, male or female, gender ratio is not limited.\n* Apply corticosteroid less than 1.0mg\u002Fkg\u002Fd.\n* Written informed consent form.\n\nExclusion Criteria:\n\n* Inability to comply with IL-2 treatment regimen;\n* Other active infections. (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus, Mycobacterium tuberculosis or pneumocystis carinii pneumonia)\n* Any anti-CMV vaccine within 6 months;\n* History of intravenous immunoglobulin (IVIG) or leflunomide within 6 months prior to randomization, and those who have undergone plasmapheresis;\n* Active severe neuropsychiatric manifestations of SLE;\n* Severe chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\\> 3N));\n* Severe complications. (respiratory failure, heart failure or toxic shock)\n* Complicated with other autoimmune diseases;\n* Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);\n* Pregnancy or lactation in females.\n* Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;\n* Participate in other clinical trial within 3 months.","65 Years",{"count":283,"type":21},100,[234],"This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.",[287,29],"SLE (Systemic Lupus)","2025-05-07",{"date":290,"type":46},"2025-05-14",{"date":292,"type":21},"2025-05-20",{"date":294,"type":21},"2025-12-30",{"name":296,"class":148},"Peking University People's Hospital",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":63,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":52},"100516972","phase-1-expansion-of-virus-specific-lymphocytes-for-cell-therapy-100516972","NCT06011486","Expansion of Virus-Specific Lymphocytes for Cell Therapy","Expansion of Virus-Specific Lymphocytes for Cell Therapy in Immunosuppressed Patients Who Underwent Bone Marrow Transplantation.","Inclusion Criteria:\n\n* Be able to provide signed informed consent.\n* Must be between 18 and 75 years old at the time of signing the consent form\n* Having undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical or cord blood transplant)\n* Negative pregnancy test for women of childbearing age (non-fertile age defined as post-menopausal over one year, or surgically sterilized); Acceptance of the use of contraceptive methods by sexually active men and women of childbearing age;\n* Present with clinically significant CMV infection and one of the following conditions:\n* Refractory CMV infection, defined as over a 1log increase in blood or plasma CMV copies number after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)\n* Probable refractory CMV infection, defined as persistence of CMV DNA in blood or plasma at the same level or under 1 log increase after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)\n* Presence of resistant CMV, defined by the presence of a known genetic mutation that reduces susceptibility to one or more antiviral medications\n* Refractory CMV disease, defined as worsening of signs and symptoms and\u002For progression to CMV disease after 2 weeks of appropriate antiviral therapy\n* Restrictions or complications related to conventional therapy, which make it impossible to carry out conventional drug treatment defined as cytopenias with neutrophils under 1000 per microliter, platelets under 100,000 per microliter related to the use of ganciclovir or valganciclovir and nephrotoxicity with an increase of 1.5 times in the baseline creatinine with the use of foscavir.\n\nExclusion Criteria:\n\n* Patients who do not meet the inclusion criteria\n* Patients who do not agree to participate in the study or sign the consent form\n* Patients reporting allergy to murine antibodies or iron-dextran\n* Patients with grade 3 or 4 graft versus host disease\u002Fgraft versus host disease in activity\u002Ftreatment\n* Pregnant or lactating patients\n* Patients with uncontrolled bacterial and\u002For fungal infections","75 Years",{"count":306,"type":21},10,[233],"Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation.\n\nIn this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private.\n\nThis project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity \u002F mortality after transplantation, as well as a reduction in the hospitalization period.",[69,29],"2024-10-22",{"date":312,"type":46},"2024-10-24",{"date":314,"type":46},"2024-06-10",{"date":316,"type":21},"2026-06-10",{"name":318,"class":148},"Hospital Israelita Albert Einstein",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":63,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":343,"locationsCount":52},"100366843","phase-2-prophylaxis-of-cytomegalovirus-infection-with-adoptive-cell-inmunotherapy-100366843","NCT04056533","Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy","Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy","INMUNOCELL","Inclusion Criteria:\n\n* Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).\n* Any source of stem cells (peripheral blood or bone marrow).\n* CMV-seropositive donors.\n* Negative pregnancy test in women.\n* Signed writen informed consent.\n* DONORS:\n\n  1. HLA haploidentical and CMV-seropositve donors.\n  2. Donor must be checked and suitable.\n  3. Signed writen informed consent.\n  4. Donor without active infection evidence at leukapheresis.\n\nExclusion Criteria:\n\n* Patients without haploidentical CMV-seropositive donors.\n* Patients who are not suitable for follow up visits.\n\nCMV-CTLs Infusion Criteria:\n\n* Hematopoiesis recovery at least partial (neutrophil counts \\>0.5x10\\^9\u002FL in at least 3 consecutive samples post-transplant).\n\nCMV-CTLs NON-Infusion Criteria:\n\n* Patients receiving corticosteroid (dose of 0.5mg\u002Fkg\u002Fday of prednisone or equivalent) at infusion.\n* ECOG \\> or = 3.\n* Organic toxicities grade \\> or = 3.\n* Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.\n* Patients with uncontroled infection defined by fevers and\u002For inestability and\u002For infection not resolved.\n* Persistent fevers 3 days before infusion.\n* Acute Graft Versus Host Disease (GVHD) grade II-IV.\n* Relapse or progression after transplant and before infusion day.\n* CMV reactivation\u002Finfection after transplant and before infusion day.\n\nPatients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.","80 Years",{"count":329,"type":21},15,[234],"Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.",[29],[334,335,336],"Citomegalovirus","Haploidentical","Hematopoietic Stem Cell Transplantation","2024-08-27",{"date":339,"type":46},"2024-08-28",{"date":341,"type":46},"2022-03-26",{"date":217,"type":21},{"name":344,"class":148},"Instituto de Investigación Marqués de Valdecilla"]