An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
Cytomegalovirus InfectionsThis retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®)...
Cytomegalovirus InfectionsThis 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.
Natural History of Cytomegalovirus (CMV) Infection and Disease Among Renal Transplant Recipients...
Infection in Solid Organ Transplant RecipientsAlthough the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased substantially over the past years, several issues still deserve further investigation. The epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive strategies currently used and growing and widespread use of prophylaxis. The knowledge of the CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among renal transplant recipients not receiving any prophylactic therapy will allow the determination of risk factors for and the impact of earlier intervention on CMV infection and disease. The goal is to ultimately improve the clinical outcomes for renal transplant recipients.
Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant...
Cytomegalovirus InfectionsPreventation of Cytomegalovirus Reactivation2 moreThis 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.
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular...
Kidney TransplantationCytomegalovirus InfectionsKidney transplant patients under an immunosuppressive treatment based on anti-calcineurin and mycophenolate-mofetil and induction therapy with rATG who suffer from early systemic viral replication by the CMV virus could benefit from the introduction of an i-mTor drug. (everolimus) to replace mycophenolate mofetil. This conversion would be effective in slowing down and controlling viral expansion without the need to initiate any prophylactic anti-viral therapy thanks to the activation of the CMV-specific cellular effector response or to an antiviral effect of i-Mtor itself.
Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
Heart TransplantationCardiac Allograft Vasculopathy1 moreCardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart transplant recipients. Although several immune-mediated and metabolic risk factors have been implicated in the pathogenesis of CAV, no effective therapy is currently available to treat established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is based on prevention and treatment of factors known to trigger its development. Although the mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV progression. Two strategies involving administration of specific anti-CMV agents are recommended for prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros and cons of the two strategies are still debated, in the absence of randomized studies addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear evidence of superiority of either approach. The investigators conceived this randomized prospective project to compare the effect of preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on one-year increase in coronary intimal thickening. Patients will be additionally randomized to receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV properties of everolimus.
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis...
Cytomegalovirus Infections21 patients were randomised to receive instructions and coaching or no intervention on the use and intake of ganciclovir. Intake of medication was measured by an electronic pill box. The duration of the study was 100 days.
CMV Glycoprotein B Vaccine in Allograft Recipients
Cytomegalovirus InfectionsPatients who receive transplants are at increased risk of developing serious cytomegalovirus (CMV) infections because they have a decreased immune system. The purpose of this study is to evaluate the safety and immune response of a CMV vaccine in patients (18 years old and older) who are awaiting a transplant. Following immunization with vaccine or placebo (inactive substance), patients will be followed for the development of immune responses to CMV and for evidence of CMV infection following transplantation. One hundred forty eligible patients will receive 3 injections of the CMV gB vaccine or 3 doses of placebo during 5 visits. Participants will participate in the study for approximately 7 months (if they do not undergo a transplant) or 10 months (if they undergo a transplant).
Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
Cytomegalovirus InfectionInfectionThis study will evaluate the reliability of a new test called Real-Time Polymerase chain reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course of CMV disease in patients who have recently had a bone marrow transplant. The test's effectiveness will be compared with that of the "pp65 antigenemia assay" now routinely used for this purpose. CMV is a common virus that is transmitted from person to person by close personal contact. In most healthy people, CVM can remain in the body indefinitely without causing any harm. But, in people with weakened immune systems-including those who have just undergone bone marrow transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are available to treat this infection, however. Optimum treatment depends on early and accurate detection. Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase 1, patients will have blood drawn for both RT PCR and antigenemia testing once before the bone marrow transplantation and then weekly for the first 100 days after the transplant. During Phase 2-which begins immediately after the end of phase 1 and continues for one year after the transplant-blood samples for both tests will be drawn up to once a week. The samples for both tests will be collected at the same time and will be taken through a catheter (a thin flexible tube inserted into a vein) that has already been placed for the transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over the course of the 1-year study. It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV infection and predicting disease development, thus enabling doctors to plan early and effective treatment.
A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis...
Cytomegalovirus RetinitisHIV InfectionsThe purpose of this study is to see if it is safe to stop maintenance therapy in HIV-positive patients with treated and healed CMV retinitis (eye disease) who have responded well to anti-HIV (antiretroviral) therapy. The current therapies available to treat CMV retinitis are long-term therapies. However, it may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs.