REVIVE: Large-scale HIV trial set to build capacity in clinical trial management in Africa
The introduction of anti-retroviral treatment (ART) for HIV infections in Africa has reduced the mortality rate from HIV by about 50% on the continent. Despite this incredible positive impact, HIV remains among the top five causes of mortality in Africa, with an estimated 460,000 deaths annually.
The Reducing Mortality in Adults with Advanced HIV Disease (REVIVE) trial, led by UCT and the Population Health Research Institute (PHRI) in Canada, and funded by the Gates Foundation, is a large, randomised controlled trial aimed at testing whether a cost-effective antibiotic intervention can increase survival in this group.
The presence of white blood cells that fight infection, known as CD4 cells, is a common way to measure the health of the immune system in people living with HIV, as HIV attacks and destroys CD4 cells. A low CD4 count renders a person unable to fight off basic infections. It has long been speculated that the high death rate of people with CD4 counts below 100 (a healthy CD4 count is over 500) is due to undetected bacterial infections that the body is unable to fight.
"In South Africa advanced HIV disease is a common problem. Our patients are very vulnerable during this time when they have low CD4 counts and are starting or re-starting antiretroviral therapy. Deaths during these first few months of ART is a persistent problem which has been largely unchanged since the start of the ART era,” said Dr Charlotte Schutz, clinical research officer at UCT's Institute of Infectious Diseases and Molecular Medicine (IDM) and the South African national lead of the REVIVE trial.
The REVIVE trial focuses on this vulnerable time period with the aim to reduce deaths by pre-emptively treating patients for serious bacterial infections with a broad-spectrum antibiotic called azithromycin.
“What makes the REVIVE trial significant is the size of it,” said Associate Professor Sean Wasserman at UCT's Division of Infectious Diseases and HIV Medicine in the Department of Medicine and scientific lead of REVIVE.
“With 8,000 participants across 14 African countries we will be able to definitively answer the question of whether the provision of azithromycin can reduce mortality rates, potentially saving many thousands of lives over time.”