25 Clinical Trials for Various Conditions
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (\>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.
The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.
This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily \[both dose adjusted per Food and Drug Administration (FDA) label\] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study. Estimated Time to Complete Enrollment: 4 years
The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.
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.
HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).
Our study will compare all kidney transplant recipients receiving valganciclovir vs. valacyclovir for one year following kidney transplant and compare: 1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after transplant. 2. the side effects of the anti-viral drugs requiring dose reduction or cessation In addition, we will test renal tissue obtained from any biopsies post-transplant (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and fluorescence in situ hybridization to assess for latent CMV and/or EBV.
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.
Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having evidence of having the infection at sometime in their life. Patients who have undergone transplantation are at risk at developing CMV, especially those patients who do not have antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they have the infection without tests to detect the virus. CMV can less commonly cause serious infections that affect many parts of the body including the intestines, liver, or lungs. In rare cases CMV infection in transplant patients can cause death. All patients who receive a transplant are monitored for CMV infection. The purpose of this study is to determine if there is a way the investigators can determine in advance which patients are at greatest risk of CMV infection. Specifically, this study will analyze the immune system of transplant patients to determine if there are specific elements of the immune system that 1) helps protect the body against CMV infection, and 2) helps the body combat CMV once it is infected. Identifying these specific elements of the immune system could improve the physician's ability to monitor the SOT patients for CMV infection, and to help treat CMV in those patients that become infected.
This study will compare different ways of giving the drugs ganciclovir and valganciclovir to kidney or kidney and pancreas transplant recipients to determine the most effective dose of valganciclovir for protecting against cytomegalovirus (CMV) infection in these patients. One of the most common viral infections following organ transplant, CMV can cause serious illness and even death. Ganciclovir reduces the incidence of CMV disease after kidney transplantation. The drug is given either intravenously (through a vein) twice a day or by mouth 3 times a day. Valganciclovir is converted to ganciclovir in the body and is absorbed into the bloodstream better than oral ganciclovir. In most transplant patients, a single daily dose of valganciclovir prevents CMV. Because of these advantages, some transplant patients are being given valganciclovir instead of ganciclovir to prevent CMV infection. However, the drug has not been studied in kidney and kidney transplant patients. This study will provide dosing information for this patient population. Patients 18 years of age and older who have had a kidney or kidney and pancreas transplant at the NIH Clinical Center may be eligible for this study. Participants will undergo the following treatments and procedures: - Phase 1 - Treatment with intravenous ganciclovir for at least 7 days after transplantation. Sometime before starting phase 2, patients will provide a 24-hour urine collection to test for kidney function. The day before starting phase 2, they will have a cannula (small needle) inserted into an arm vein for about 12 hours to draw blood samples-one before starting the ganciclovir infusion, then at 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours after the dose. * Phase 2 - Treatment with oral valganciclovir once a day for 7 to 21 days at a dose approximately equivalent to intravenous ganciclovir. Sometime between 4 and 21 days on this dose, patients will have blood sampling in the morning before taking the drug and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose. * Phase 3 - Treatment with valganciclovir at a dose reduced by half to approximate oral ganciclovir dosing. After at least 4 days on this dose, patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours after the dose. Kidney function will be assessed by blood tests within 2 days of the blood sampling. If kidney function is not within the normal range, further dosing and blood sampling will be delayed until kidney function returns to the normal range. - Phase 4 - Treatment with oral ganciclovir every 8 hours. After at least 4 days on this regimen, patients will be admitted to the hospital for 1 day for blood sampling before the drug dose and then at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after the dose. Kidney function will be estimated by blood tests within 2 days of the blood sampling. If kidney function is not within the normal range, further dosing and blood sampling will be delayed until kidney function returns to normal range. After completing phase 4, patients will continue valganciclovir daily or oral ganciclovir treatment and blood sampling for a length of time prescribed by the transplant surgeon.
This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the study: Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month. Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.
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 detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).
To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor
The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are Valganciclovir (FDA approved to prevent and treat CMV infection) vs Maribavir (FDA approved to treat CMV infection) plus Acyclovir (FDA approved to prevent HSV infection).
CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usually after the drug has been stopped, the patient develops the viral disease. Extended use of anti-viral drugs may, in fact, may lead to the development of resistant virus. We hypothesize that extended use (12 months) of valganciclovir (Valcyte™)will not only be efficacious but will not be associated with the development of resistant CMV. Sample Size: 100 patients at 3 sites have been enrolled Patient Selection: Adult (\>18 years) recipients of cadaveric or living donor kidneys, pancreas, or combine kidney-pancreas transplants. Immunosuppression: To be determined according to each center's standard protocol (s). Study Drug: Valcyte™ Days 0 - 90: All Patients, 900 mg QD Days 91 - 365: Group 1: 900 mg QD Group 2: 450 mg QD Assessment of Valgancicovir (Valcyte™)Resistant CMV : Serial serum samples (at transplant, 6 weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54 genes. Other Analyses: Additional information will be evaluated relating to the development of CMV disease, development of ganciclovir toxicity, graft rejection or graft loss and patient death. Preliminary information regarding the predictive value of DNA assays for the development of CMV disease will be evaluated.
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy.
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus. PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.
RATIONALE: Vaccines may help the body build an effective immune response to kill cytomegalovirus infections. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy.
RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation. PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes