Letermovir Pill for Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Minnesota, Minneapolis, MN
Infections+5 More
Letermovir Pill - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help prevent CMV infection in people who have already had CMV.

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Eligible Conditions

  • Infections
  • Cytomegalovirus (CMV) Infection
  • CMV
  • Hematopoietic Cell Transplant

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Letermovir Pill will improve 1 primary outcome in patients with Infections. Measurement will happen over the course of up to 24 weeks from time of study treatment.

Week 24
The rate of breakthrough clinically significant Cytomegalovirus (CMV) infection by week 14

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Hematopoietic cell transplantation/HCT
1 of 1
Experimental Treatment

This trial requires 86 total participants across 1 different treatment group

This trial involves a single treatment. Letermovir Pill is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Hematopoietic cell transplantation/HCTParticipants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. OBSERVATIONAL COHORT: Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks from time of study treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 weeks from time of study treatment for reporting.

Closest Location

University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Infections or one of the other 5 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Treatment is indicated for patients who have received preemptive therapy for clinically significant CMV infection post-HCT and have completed preemptive therapy no longer than 7 days prior to enrollment. show original
Patients must be at least 12 years of age show original
Have received allogenic HCT

Patient Q&A Section

What are the signs of cytomegalovirus infections?

"CMV antibodies, such as anti-CMV IgM levels, IgG levels, and IgA levels can be of value to make differentiating diagnosis from a diagnosis of URTI or pneumonia and rule out severe disease and mortality. Immunohistochemistry detection and staining of viral antigen can rule out CMV infection. CMV antibody serology and cytomegalovirus DNA analysis should be performed on patients with URTI and in those patients with pneumonia with a history of exposure to CMV or a high risk for serious complications." - Anonymous Online Contributor

Unverified Answer

Can cytomegalovirus infections be cured?

"Infections of HCMV are associated with prolonged hospital stay and increased risk of nosocomial infection. In addition, they are associated with increased morbidity and mortality. Vaccination does not significantly affect the incidence of HCMV infection or complications." - Anonymous Online Contributor

Unverified Answer

What causes cytomegalovirus infections?

"Cytomegalovirus infections can vary in severity, which is determined by a number of biological and environmental factors. However, the main cause is the lack of cell-mediated immunity, and it tends to cause a high virus load." - Anonymous Online Contributor

Unverified Answer

How many people get cytomegalovirus infections a year in the United States?

"Cytomegalovirus seropositivity in the general US population is 1.1%, and the prevalence is highest (14.9%) in persons 20-59 years old. However, the epidemiology and clinical significance of cytomegalovirus seropositivity are not well defined." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cytomegalovirus infections?

"The most commonly prescribed antiviral medications for cytomegalovirus are ganciclovir, valganciclovir, and foscarnet. Other medications that may be used in the treatment of cytomegalovirus infections include ciprofloxacin and penicillin. There seems to be no consensus about the use of antiviral medication for cytomegalovirus infection from a Cochrane review. There is a paucity of data on the natural history of cytomegalovirus infection in the literature." - Anonymous Online Contributor

Unverified Answer

What is cytomegalovirus infections?

"While no specific antiviral therapy has been found to be effective in CMV infection, several other strategies, including pre-emptive antiviral prophylaxis in at-risk transplant patients and the treatment of all symptomatic immunocompromised patients, have been advocated by the medical community. This report, as well as earlier ones, supports the conclusion that CMV infections in immunocompetent patients have a low risk for inducing the development of malignancies." - Anonymous Online Contributor

Unverified Answer

How does letermovir pill work?

"The treatment was well-tolerated and resulted in an increase in the cell-specific immune response, suggesting that this antiviral-based approach has the potential to interfere with viral replication." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving letermovir pill?

"Although clinical trials could potentially be used for safety, regulatory concerns should still be considered in the development of this agent. A Phase III trial is in progress for the treatment of CMV retinitis in HIV-infected patients in the US." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cytomegalovirus infections?

"There are no reports of HCP infection causing HCMV reactivations or infections in pediatric patients. Although HCMV infections are rarely reported in healthy nonimmune pediatric patients, and the reactivation is more commonly reported in immunocompetent patients, most patients with HCMV infections also had some underlying immunosuppression. A diagnosis of HCMV infection in children who are healthy must be based primarily on clinical findings of infection or serology for HCV or HIV or CMV IgM. The diagnosis can be difficult because there are rare reports of symptomatic disease associated with HCMV." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cytomegalovirus infections?

"The number of trials that were included were larger than the number of people that were enrolled, which is not a very good indicator of trial quality." - Anonymous Online Contributor

Unverified Answer

Is letermovir pill safe for people?

"This was a small study, though one that included all the major drug-gadgets that might cause CMV-related illness in people being treated with letermovir. No data on the long-term outcome and no information was available on treatment interruption, dose, drug interactions or viral coinfection. Data on adverse events are needed to assess the safety of letermovir and for longer-term safety. A further randomized controlled trial, powered for occurrence of serious adverse events, would be required without question to evaluate letermovir in the long term. Inclusion of people living and working in the Western Cape with recurrent CMV exposure would make a significant contribution towards this end." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cytomegalovirus infections?

"The incidence for cytomegalovirus (CMV) is not associated with risk group. CMV is the most frequent cause of acute kidney disease in critically ill patient. The treatment should be considered depending on their condition. Patients with high risk should be treated early with antiviral therapy. However, the number of patients with CMV complication is still minimal due perhaps partly to the rarity of the condition. Therefore, future investigation is needed in the treatment of CMV infection. The treatment of CMV viremia in HIV positive patient is similar to the general guideline." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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