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Cytomegalovirus Infections clinical trials

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NCT ID: NCT03728426 Not yet recruiting - Clinical trials for Cytomegalovirus Infections

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection

Start date: November 2018
Phase: Phase 2
Study type: Interventional

The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.

NCT ID: NCT03722615 Recruiting - Hearing Loss Clinical Trials

Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa

Start date: May 6, 2016
Phase:
Study type: Observational

The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV) infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant pairs, screening mothers for CMV infection and newborns for congenital CMV infection. Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood. Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on newborn saliva and urine within 3 weeks of birth. Various risk factors associated with congenital CMV such as HIV exposure, and gestational age will be assessed. The association between maternal vaginal CMV shedding postnatally with congenital CMV infection will be explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis. Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a cohort to be followed up until 12 months of age monitoring for various neurological sequelae such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and seizures. A comparison of vaccine immune responses between cases of congenital CMV and the CMV uninfected infants to the primary series of vaccines in the National Expanded Programme on Immunisation will be compared. The contribution of CMV infection to neonatal death and stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies that die during the neonatal period and stillbirths.

NCT ID: NCT03698435 Recruiting - Clinical trials for Cytomegalovirus Infections

(Val)Ganciclovir TDM in Transplant Recipients

Start date: May 25, 2018
Phase:
Study type: Observational

The aim of this study is to gain more insight into therapeutic drug monitoring and thus the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.

NCT ID: NCT03631316 Recruiting - Clinical trials for Kidney Transplantation

Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Cytomegalovirus (CMV) is the most common opportunistic viral pathogen in solid organ transplant receptors (SOTR). In Mexico, the experience using generic immunosuppressants have been demonstrated a wide variation in the pharmacokinetic parameters between generic and innovative formulation, resulting in a suboptimal absorption of the drug and reaching infratherapeutic trough levels in blood. In this study the investigators will compare the pharmacokinetic parameters of innovative and generic valganciclovir in renal transplant recipients.

NCT ID: NCT03576898 Not yet recruiting - Clinical trials for Cytomegalovirus Infections

Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis

STACCATO
Start date: January 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Recurrent anterior uveitis in immunocompetent individuals can be caused by multiple members of the herpes virus group, including cytomegalovirus (CMV). Repeated bouts of CMV intraocular inflammation can be associated with ocular hypertension, glaucoma, pain, vision reduction or blindness. CMV anterior uveitis is commonly misdiagnosed as a non-infectious anterior uveitis and treated as such, which can beget further complications. Diagnosis requires directed polymerase chain reaction (PCR) testing. While antiviral therapy exists for CMV, identifying the appropriate therapy has been challenging because no randomized trials comparing routes of therapy (particularly oral or topical) have been performed. Currently, CMV anterior uveitis is typically treated with oral valganciclovir in the United States but carries the risk of serious systemic side effects that necessitate laboratory monitoring. There is evidence that suggests topical ganciclovir can be used to treat and prevent recurrences of CMV anterior uveitis, though the appropriate concentration is not well defined. Topical ganciclovir is attractive because it does not require laboratory monitoring, though a unique side effect profile that includes corneal epitheliopathy and conjunctivitis may preclude long-term use. While anterior chamber paracentesis with polymerase chain reaction (PCR) testing demonstrates CMV during an initial flare of inflammation, it is unknown whether repeated recurrences of inflammation are mediated by viral re-infection and replication in the anterior chamber or if a sterile immune response is at play. Consequently, patients may be submitted to many years of oral or topical antiviral therapy. This strategy poses challenges without proper evaluation of the multiple treatment and long-term management approaches. Further studies are needed to elucidate the most appropriate antiviral therapies that balance efficacy and toxicity while treating CMV anterior uveitis. We hypothesize that the efficacy of oral valganciclovir in the treatment of cytomegalovirus (CMV) anterior uveitis will be greater when compared to topical or placebo treatments. This study will be a multicenter, double-masked, randomized, placebo-controlled clinical trial.

NCT ID: NCT03576014 Recruiting - Clinical trials for Cytomegalovirus Infections

Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient

Start date: April 27, 2018
Phase: Phase 1
Study type: Interventional

This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients. The recommended dose will be selected based on the safety and tolerability profiles observed.

NCT ID: NCT03511274 Recruiting - Clinical trials for Cytomegalovirus Congenital

Reducing Acquisition of CMV Through Antenatal Education

RACEFIT
Start date: January 17, 2017
Phase: N/A
Study type: Interventional

The evidence to date indicates that educational strategies may be effective at reducing antenatal CMV infection, however these have not been tested in the UK. In phase 1 of the study, the investigators will co-design an educational intervention with pregnant women and families affected by congenital CMV with the aim of reducing the risk of acquisition of CMV in pregnancy. In phase 2 of the study, the investigators will use this educational intervention in a randomised controlled trial (RCT) as part of a feasibility study to generate the data required for the design of a future main RCT. Should the future main RCT show that the educational intervention is effective in reducing the risk of primary CMV infection in pregnancy, the intervention could be rolled out in the National Health Service (NHS). This would have significant benefits to patients and the NHS. No other single cause of congenital defects and long-term developmental disability currently provides greater opportunity for improved outcomes than the prevention of congenital CMV, therefore trials designed to test prevention strategies should be a research priority for the NHS.

NCT ID: NCT03486834 Recruiting - Clinical trials for Cytomegalovirus Infections

Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.

NCT ID: NCT03475212 Recruiting - Clinical trials for Cytomegalovirus Infections

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation

ACES
Start date: June 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.

NCT ID: NCT03467841 Not yet recruiting - Cmv Colitis Clinical Trials

Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis

Start date: August 1, 2018
Phase:
Study type: Observational

Aim of the work - To identify the prevalence of CMV infection in patients with steroid-refractory ulcerative colitis. - To assess the clinical and endoscopic conditions in these patients.