[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cmv-viremia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cmv-viremia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,74,101,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100636857","phase-4-letermovir-vs-valganciclovir-in-cmv-r-kidney-transplant-100636857",false,"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","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28,29],"CMV Infection","CMV","CMV Viremia","CMV Disease",[27,31,32,33,34,35,36],"Kidney Transplant","Letermovir","Moderate Risk","CMV Prophylaxis","Valganciclovir","Neutropenia","NOT_YET_RECRUITING","2026-05-06",{"date":40,"type":41},"2026-05-08","ACTUAL",{"date":43,"type":20},"2026-05",{"date":45,"type":20},"2028-11",{"name":47,"class":48},"Elisabeth Kincaide","OTHER_GOV",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100622440","phase-2-trial-to-study-anti--hcmv-therapy-in-breast-cancer-patients-with-progressive-intracranial-metastases-and-cmv-infection-100622440","NCT07383649","Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection","Initial Safety Lead-in Followed by a Phase II Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (The Breast CMV Study)","Inclusion Criteria:\n\n1. Male or female aged \\>18 years at the time of consent\n2. Breast cancer with progressive brain metastases supra and\u002For infratentorial. Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon\u002Fradiation oncologist.\n3. At least one non irradiated, untreated progressive brain metastases site\n4. Serum HCMV DNA by real time PCR \\> 250 copies\u002Fml or positive CMV Ig G or Ig M.\n5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. If the patient is unable to consent for any reason a legally authorized guardian may provide consent on their behalf. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) will be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.\n6. Metastatic breast cancer who has systemically no evidence of disease, complete remission, partial remission, stable or progressive disease\n7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n8. Adequate hematology without ongoing transfusion support (hemoglobin \\> 9 g\u002Fdl, absolute neutrophil count (ANC) \\> 1500 per mm3 , platelets \\> 100,000 per mm3)\n9. Adequate renal and hepatic function (creatinine clearance \\[CrCL\\] \\> 60 mL\u002Fmin, bilirubin x:≤1.5 upper limit of normal (ULN), aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] ≤ 2.5 x ULN and serum albumin ≥ 3 g\u002Fdl.\n10. Other CMV treatment if clinically indicated per physician's choice\n11. Evidence of postmenopausal status or negative serum pregnancy test for premenopausal female patients. Negative serum β-human chorionic gonadotropin pregnancy test within 7 days prior to the first dose of study treatment for premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n\n    The following age-specific requirements apply:\n12. Women \\\u003C50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n13. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n14. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Single resectable intracranial lesion\n2. Last intracranial progression free survival \\> 12 months\n3. All progressive brain metastases have been radiated\n4. Brain metastases needing immediate local intervention such as mass effect, herniation, active neurological symptoms, increased intracranial pressure, those near vital structures like the motor cortex, proximity to the optic nerve\u002Fchiasm or brain stem etc (can still be included if there are any other non-radiated progressive brain metastases) Multidisciplinary discussion with neurosurgery and radiation oncology will be needed to determine which patients may be safely enrolled on the trial.\n5. Active pregnancy or breast feeding\n6. Women of childbearing potential or fertile men unwilling to use effective contraception (Section 6.2, Table 6) during study and up to three months after treatment discontinuation.\n7. Known psychiatric disorder that causes poor cooperation with the trial requirements.\n8. Participants with previous other malignancies must have had at least a 3-year disease free interval, except those with non-melanoma skin cancer or carcinoma in situ of cervix\n9. Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.\n10. Concurrent enrollment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n11. Unresolved or unstable adverse events (AEs) from prior administration of another investigational drug, per investigators' discretion.\n12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.\n13. Non-English-speaking subjects will not be enrolled in this study since the neurocognitive tests including DKEFS, RAVLT and TMT are not validated to be scored in other languages.",{"count":58,"type":20},28,[60],"PHASE2","This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female patients, aged ≥18 years, who have metastatic breast cancer with progressive brain metastases and CMV viremia (\\> 250 copies\u002Fml) or positive CMV IgG or IgM will be eligible to participate in the trial.\n\nPatients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon\u002Fradiation oncologist. At least 10 patients will be enrolled in the initial safety lead-in followed by the Phase II trial which will include 18 patients.\n\nAnti-HCMV therapy, oral Valganciclovir will be given to patients at 900 mg twice a day for 2 weeks. After the induction period, the maintenance will be continued with valganciclovir at 450 mg twice daily for 4 weeks (28 days).",[63,28],"Brain Cancer Metastatic","RECRUITING","2026-04-07",{"date":67,"type":41},"2026-04-08",{"date":43,"type":20},{"date":70,"type":20},"2030-05",{"name":72,"class":73},"The Methodist Hospital Research Institute","OTHER",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100599072","phase-2-valganciclovir-vs-letermovir-for-cmv-prophylaxis-in-heart-transplant-100599072","NCT07079735","Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant","VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)","VALET-CMV","Inclusion Criteria:\n\nPatients who are \\>18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.\n\nExclusion Criteria:\n\nHistory of or suspected CMV disease within 6 months prior is excluded.","99 Years",{"count":84,"type":20},150,[60,86],"PHASE3","The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.",[28,89,90],"Heart Transplant Infection","Heart Transplant Failure and Rejection","2025-09-22",{"date":93,"type":41},"2025-09-25",{"date":95,"type":41},"2025-09-12",{"date":97,"type":20},"2029-01-17",{"name":99,"class":73},"Columbia University",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":49},"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":110,"type":20},10,[112],"PHASE1","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.",[28,27],"2024-10-22",{"date":117,"type":41},"2024-10-24",{"date":119,"type":41},"2024-06-10",{"date":121,"type":20},"2026-06-10",{"name":123,"class":73},"Hospital Israelita Albert Einstein",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":49},"100472507","phase-2-cytomegalovirus-prophylaxis-with-letermovir-in-heart-transplant-recipients-100472507","NCT05432778","Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients","Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study","CYPHER-TXPilot","Inclusion Criteria:\n\n* heart transplant recipient (new)\n* moderate (D+\u002FR+ and D-\u002FR+) or high (D+\u002FR-) risk CMV serostatus\n* signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* short-term mechanical circulatory support prior HTX\n* ongoing CMV infection\u002Fdisease\n* D-\u002FR- CMV serostatus\n* heart re-transplantation\n* need for intensified immunosuppression protocol\n\n  * \\>20% cytolytic alloantibodies prior transplant\n  * perioperative (within 7 days after HTX) allograft rejection \\> 1R\n* immunoinduction with ATG\n* pregnancy\n* active participation in another interventional clinical trial\n* know hypersensitivity to letermovir\n* known hypersensitivity to valgancyclovir\n* known hematological disorders (apart from anemia)","70 Years",{"count":134,"type":20},90,[60],"CMV infection is the most prevalent infection after heart transplantation (HTX), occurring in up to 40-60% of the recipients. It most frequently occurs within the first 6 months after transplantation and commonly presents as an asymptomatic viral replication. Viral syndrome or tissue-invasive disease (gastroenteritis, pneumonitis, myocarditis or meningitis) are much less common. Even though CMV infection is generally treatable with virostatic therapy and\u002For CMV-specific immunoglobulins, direct effects of CMV infection (viral syndrome and tissue-invasive disease) and general and transplant-specific indirect effects of CMV infection have been associated with significant morbidity and mortality in HTX patient population, mainly due to graft loss, development of malignancies, or opportunistic infections. According to the latest consensus paper on CMV prophylaxis and treatment in solid organ transplant recipients, valgancyclovir (or its active form gancyclovir) represents a virostatic therapy of choice for CMV prophylaxis and treatment after HTX. However, valgancyclovir has an array of side effects including hematological (leukopenia, neutropenia, anemia, thrombocytopenia), neurologic (headache, insomnia), gastrointestinal (decreased appetite, diarrhea, vomiting and dyspepsia) and psychiatric (depression) disorders. These can either expose HTX patients to additional complications (e.g. leukopenia and\u002For neutropenia can result in systemic fungal infections), decrease patients' quality of life, or mandate a decrease in valgancyclovir dose, which exposes patients to an increased risk for CMV reactivation. Recently, letermovir (a novel CMV viral terminase inhibitor), was approved for CMV prophylaxis in allogeneic bone marrow transplant recipients as the placebo-controlled study showed that significantly less patients, treated with letermovir, developed CMV disease (37% vs. 60%; P\\\u003C0.001) and there was also a trend towards lower all-cause mortality. Data on bone marrow transplant recipients additionally suggest that letermovir is generally well tolerated with side effects limited to mild gastrointestinal symptoms (diarrhea, nausea). Importantly, myelosuppresive side effects of letermovir occur very rarely. Some encouraging data does exist on the use of letermovir in kidney transplant recipients, where a recently published proof-of-concept trial (N=27) suggested comparable safety and efficacy of leteremovir (N=18) and valgancyclovir (N=9): both treatment regimens resulted in similar time-course of viral load reduction and viral clearance and were well tolerated in terms of adverse events. Currently, a Phase III clinical trial is ongoing in renal transplant recipients (Clinicaltrials.gov: NCT03443869) to confirm this pilot data. However, to date, there is no published data on the use of letermovir in patients after HTX.\n\nBased on the results in kidney transplantation, the aim of this pilot study is thus to evaluate the effects of letermovir-based CMV prophylaxis in heart transplant recipients.\n\nThe primary objective of the study is to investigate the efficacy of letermovir-based CMV prophylaxis in patients after heart transplantation.\n\nThe secondary objectives of the study are:\n\n* to investigate the tolerability of letermovir-based CMV prophylaxis in patients after heart transplantation.\n* to explore the potential correlation between letermovir-based CMV prophylaxis and restitution of cell-regulated immunity in patients after heart transplantation.",[28],[139,140,141],"CMV reactivation","letermovir","heart transplantation","2023-11-06",{"date":144,"type":41},"2023-11-09",{"date":146,"type":41},"2023-05-01",{"date":148,"type":20},"2026-08-01",{"name":150,"class":73},"University Medical Centre Ljubljana"]