Clinical Research Directory

ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse

Sponsor: Wits Health Consortium (Pty) Ltd

Summary

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.

Official title: A Phase 2b Randomised Placebo Controlled Trial of Valganciclovir for Cytomegalovirus Viraemia in Adults and Adolescents With Advanced HIV Disease

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