The SMART trial in the field of HIV/AIDS research
The SMART trial was a major study in the field of HIV/AIDS research and had been ongoing for four years before being halted. The trial was designed to compare two different treatment strategies for HIV-positive patients: continuous antiretroviral therapy (ART) and episodic drug treatment guided by CD4+ cell levels. The goal of the trial was to determine which strategy resulted in greater overall clinical benefit for patients.
The trial involved more than 5,000 HIV-positive volunteers from 33 countries and was conducted by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH) in the United States. The trial had successfully recruited more than 90% of its target of 6,000 participants before being halted.
The trial's findings were significant, as they demonstrated that patients receiving episodic therapy had twice the risk of disease progression and major complications, such as cardiovascular, kidney, and liver diseases, compared to patients on continuous ART. These complications had been associated with ART, and it was hoped that they would be seen less frequently in patients receiving less drug. However, the findings showed the opposite, leading to the decision to halt enrollment.
The decision to halt enrollment was made by the NIAID in collaboration with the study's Executive Committee and following a recommendation from an independent Data and Safety Monitoring Board (DSMB). The DSMB was charged with regularly evaluating data and safety issues during the multi-year trial.
