Clinical Trials for Cytomegalovirus Infections

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Cytomegalovirus Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 29
• Active, not recruiting: 3
• Completed: 12
• Other: 6

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01011712 — The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise

Background:

• 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 st…

NCT07477925 — Immunological and Virological Prognostic Markers of Human Cytomegalovirus (HCMV) Congenital Infection in Pregnant Women With Primary HCMV Infection.

Human cytomegalovirus (HCMV) establishes a lifelong relationship with its host: primary infection is followed by a latency phase with intermittent reactivation episodes, despite a robust, long-lasting immune response. Primary and non-primary infection (the latter indicating both reactivation and re-infection) is usually asymptomatic in immunocompetent individuals.

Apart from immunocompromised …

NCT03665675 — Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT

This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus [CMV] specific cytotoxic T-lymphocytes [CTLs]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific [AdV] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transpl…

NCT04439916 — Breakthrough CMV Lung Transplant -Multicentre

Cytomegalovirus (CMV) infection is the most common opportunistic infection in lung transplantation leading to direct and indirect effects that can result in life threatening complications. The risk of CMV infection is highest when the recipient of the transplant has never been in contact with CMV (negative immunity) and the donor had previous contact with CMV (positive immunity). This is called…

NCT04013802 — TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.

The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have received a product that depletes virus specific T cells.

The patient must have had a myeloablati…

NCT05183490 — R-MVST Cells for Treatment of Viral Infections

The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy …

NCT05101213 — Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients

This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic option…

NCT05234723 — Ganciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients

The ReCySOHT study is a multicenter, retrospective, observational case-control study on the risk factors for developing a ganciclovir-resistant/refractory (GCV-RR) cytomegalovirus infection in patients receiving solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT). Aims of the study are to investigate the incidence of and risk factors for GCV-RR CMV infection in SOT recipie…

NCT05564598 — CMV CTLs in Neonates With CMV Infection

Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened.

All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or …

NCT05446571 — Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

The investigators’ hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP).

The main objective is to demonstrate that Letermovir administered to …

NCT05319353 — A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension.

The participants will be treated with maribavir for 8 weeks.

Participants need to visi…

NCT06066957 — Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. The study hypotheses are:

1. Letermovir prophylaxis will be associated with similar rates of CMV infection as valganciclovir among heart and lung transplant recipients
2. Letermovir will be better tolerated than valganciclovir for CMV prophylaxis in heart and lung …

NCT06494033 — Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients

The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants’ body. Therefore, the study team will follow the participants’ immunological response based on the Cytomegalovirus (CMV) virus testing.

NCT05711667 — A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients

This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body’s natural infection-fighting ability and increase the likelihood of an infect…

NCT06407232 — Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.

NCT06213974 — A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina

The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina.

The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.

Participants will be treated by their doctors according to normal medical practice. Study data will be col…

NCT06118515 — A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects will receive one dose of oral letermovir (Study Day 0), using the dose bands. A full pharmacokinetic…

NCT06694428 — Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals

Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-sp…

NCT06916195 — Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation

This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.

NCT06853184 — Study Evaluating the Efficacy and Safety of Artesunate

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.

NCT07569653 — Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.

The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus [CMV] infection) based on the recovery of the patient’s own immune system.

Cytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typi…

NCT07670468 — Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.

The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:

• What is the maximum tolerated dose of LB-D…

NCT07685457 — Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.

The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:

• What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting to…

NCT07511127 — Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT

To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.

NCT07635368 — Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection

This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.

NCT07679412 — Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.

The goal of this exploratory clinical study is to evaluate the safety and efficacy of Cytomegalovirus-Specific T cells (LB-DTK-CMV) to treat patients diagnosed with antiviral-resistant and refractory cytomegalovirus retinitis. The main questions it aims to answer are:

• What adverse events occur after the infusion of LB-DTK-CMV?
• What is the duration of efficacy following treatment?
• Is ther…

NCT07383649 — Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection

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…

NCT07688759 — CMV-CMI in csCMVi After HSCT

Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control.

This prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV…

NCT03159364 — Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections

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. Unfor…

Active, Not Recruiting

NCT02210078 — Donor Cytomegalovirus-Specific Cytotoxic T-Lymphocytes in Treating Patients With a Persistent Cytomegalovirus Infection

This phase II trial studies how well donor cytomegalovirus-specific cytotoxic T-lymphocytes work in treating patients with a cytomegalovirus infection that has come back or has not gotten better despite standard therapy. White blood cells from donors who have been exposed to cytomegalovirus may be effective in treating patients with a cytomegalovirus infection.

NCT02506933 — Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant

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 un…

NCT05683457 — A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.

Not Yet Recruiting

NCT07488481 — Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

Donor organs often carry latent Cytomegalovirus (CMV) infection that may be transmitted to the recipient. The goal of this clinical trial is to determine the safety of SYN002 treatment during Ex-Vivo Organ Perfusion (EVOP) in clinical kidney transplantation. Donor kidneys will be treated on the EVOP system with SYN002 in order to decrease the burden of latent CMV in the organ and mitigate the t…

NCT07570433 — HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial

Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.

Cell-mediated immunity plays a crucial role in controlling CMV replication after transplantation. Immune monitoring involves the use of immune biomarkers to dynamically estimate the risk of CMV replication. This approach allows for the individualization of preventive and therapeutic st…

NCT07571135 — Letermovir vs Valganciclovir in CMV R+ Kidney Transplant

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.

The mai…

NCT07513623 — Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II

The goal of this clinical trial is to compare antiviral treatment strategies for cytomegalovirus (CMV) anterior uveitis - a viral infection causing inflammation inside the front of the eye - in immunocompetent adults aged 18 years and older. The main questions it aims to answer are:

Does oral valganciclovir reduce aqueous humor CMV viral load more effectively than topical ganciclovir 2% eye dr…

Enrolling by Invitation

NCT06027879 — Anti-viral T-cell Therapy by Gamma Capture

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥1/6 Human Leukocyte Antigens (HLA) -matched, viral specific T cells have efficacy against adenovirus, Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) in subjects who have previously received any type of allogeneic Hematopoietic Cell transplant (HCT) or solid organ transplant (SOT) or have compromised imm…

Completed Trials

NCT00023036 — Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts

This study will try to identify and understand the genetic factors that lead to an inner ear malformation called “enlarged vestibular aqueducts”, that can be associated with hearing loss.

Patients with sensorineural hearing loss with or without inner ear malformations and their parents and siblings may be eligible for this study. Participants and their immediate family members, may undergo som…

NCT04067869 — Cytomegalovirus Infection in Patients With HIV-1 Infection

The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomegalovirus infection and auto-immune disorders.

NCT02139423 — Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening

Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in…

NCT03339661 — Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T Cells Immunomonitoring.

In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction. To date, it is not certain that secondary prophylaxis allows reducing these relapses, although this prophylaxis is part of the current recommendations. Our team has recently shown that the expans…

NCT03924219 — CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detect…

NCT04232280 — Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.

NCT04615715 — Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.

NCT04732260 — Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - CYMEVALIII STEP1

In the model of the perfused cotyledon, Letermovir crosses the placenta to reach appropriate fetal concentration. The cotyledon model can only be performed in the third trimester placenta. Although it is probable that the transplacental passage in the second trimester is in the same range than the one found in the 2th trimester, it needs to be confirmed. The study will be divided in 2 steps: st…

NCT05099965 — Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)

A5355 was a randomized, placebo-controlled study conducted at US sites to evaluate the safety and immunogenicity of two injections of the study drug Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex®) in adults with both HIV and CMV. Participants were randomly assigned to receive either two injections of Triplex® or placebo at Entry/Day 0 and week 4.

The primary …

NCT04934527 — Association of T Gamma Delta-CD16+ Cells and Anti-CMV Immunoglobulins in the Prevention of CMV Infection

CMV infection in transplantation remains the most frequent infectious complication causing increased morbidity and mortality. International recommendations advocate prevention of this infection by instituting direct antiviral treatment or monitoring viral replication by PCR with the start of curative antiviral treatment when the DNAemia is positive.

The risk of CMV infection varies according t…

NCT05041426 — Letermovir for CMV Prevention After Lung Transplantation

This is an interventional, open-label, single center, pilot study with historical controls to test the efficacy of letermovir (LET) for the prevention of CMV infection and disease in adult lung transplant recipients (LTRs) with idiopathic pulmonary fibrosis (IPF).

NCT05958186 — A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China

The goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in China. The main questions it aims to answer are:

• The incidence of Cytomegalovirus (CMV) Infections (including clinical significant CMV reactivations and CMV Diseases) among children and adults Liver transplantation patients in China
• All-cause Mor…

Other (Terminated)

NCT04364178 — Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV or EBV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown prom…