Clinical Research Directory

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 transmission of cytomegalovirus (CMV).

ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse

The goal of this clinical trial is to learn if valganciclovir works to treat cytomegalovirus (CMV) infection in people with advanced HIV disease. It will also look at the safety of valganciclovir and how the body handles the drug. The main questions this study aims to answer are: Does valganciclovir safely lower the amount of CMV virus in the blood of people with advanced HIV disease? What medical problems or side effects do participants have when taking valganciclovir? Researchers will compare valganciclovir to a placebo (a look-alike tablet that does not contain any active drug) to see if valganciclovir works better than no treatment for CMV. Who can take part Adults and adolescents (15 years and older) who: Are living with HIV Have a CD4 count of 100 or less (meaning their immune system is very weak) Have CMV detected in their blood People who are pregnant, breastfeeding, very unwell, or have certain blood or kidney problems cannot take part. What will happen in the study Participants will: Be randomly assigned (like flipping a coin) to take either valganciclovir 900 mg or a placebo once a day for 4 weeks Continue to receive standard medical care for HIV and any other infections Be followed for 12 weeks after starting the study treatment During this time, participants will: Have blood tests to check CMV, HIV, and general health Have regular medical check-ups (daily in hospital, then at weeks 1, 2, 3, 4, 8, and 12) Be monitored closely for side effects, such as low blood counts or kidney problems Why this study is important Even though HIV treatment is widely available, many people still come to hospital with advanced HIV disease. In this group, about one in five people die despite starting antiretroviral therapy (ART). Reactivation of CMV is very common in these patients and has been linked to a higher risk of death. Valganciclovir is a medicine that stops CMV from multiplying. If it proves to be safe and effective in this study, it could become part of routine care to help reduce deaths in people with advanced HIV disease. Study design Type: Phase 2b, double-blind, randomised, placebo-controlled trial Sites: Helen Joseph Hospital (South Africa) and Mulago National Referral Hospital (Uganda) Number of participants: 150 (130 in the main trial, 20 in a smaller sub-study) Duration: Each participant will be followed for 12 weeks; total study duration about 2 years Possible risks and benefits Risks: Valganciclovir can cause low white blood cells, anaemia, or low platelets. These effects will be checked for regularly, and treatment will be stopped if unsafe levels are found. Benefits: The study may or may not directly benefit participants. However, it could provide important information that helps improve care for people with advanced HIV disease in the future. Oversight and safety The study is being conducted by researchers in Uganda, South Africa, the UK, and the USA, and follows international Good Clinical Practice (GCP) guidelines. An independent Data Safety and Monitoring Committee (DSMC) will regularly review safety information to protect participants.

CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

Cytomegalovirus (CMV) is a significant opportunistic pathogen and a major cause of morbidity and mortality in solid organ transplant recipients. CytoGam - Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), is an immunoglobulin G containing a standardized amount of antibody against CMV. CytoGam is obtained from pooled adult human plasma that has been selected for high anti-CMV titers. This study will evaluate if administration of CytoGam to organ transplant recipients with CMV infection, along with standard of care antiviral medication, leads to faster clearance of CMV from the blood, prevents the development of antiviral resistance, and decreases the rate of recurrence of CMV infection.