At the time of the DSMB review, the average follow-up was approximately 15 months. The analysis revealed that participants on CD4+ cell-guided episodic treatment faced more than twice the risk of disease progression relative to participants on continuous ART. Furthermore, there was an increase in major complications such as cardiovascular, kidney and liver diseases in the participants on the drug conservation arm. These complications have been associated with ART, and it was hoped that they would be seen less frequently in those patients receiving less drug.
Although the risk-to-benefit ratio of drug conservation over the longer term remains uncertain, the DSMB recommended that enrollment into the trial be halted in light of the findings to date, and the SMART Executive Committee and NIAID agreed with the recommendation. Upon reviewing the results, the Executive Committee also conveyed to local study investigators its recommendation that it would be prudent to re-initiate therapy in ART-experienced patients in the drug conservation arm. All study physicians and participants are being notified of the findings and recommendations.
Follow-up visits will continue for all participants in the SMART trial while the study team considers plans for longer follow-up.
The investigators will analyze the SMART study data in detail to gain insights into the reasons for the increased risk.
"SMART is one of the largest HIV/AIDS treatment trials ever conducted," notes NIAID Director Anthony S. Fauci, M.D. "The study reflects an extraordinary global collaboration among hundreds of dedicated AIDS clinicians and thousands of their patients, all of whom should be commended for their exceptional achievement in contributing to this pivotal HIV/AIDS treatment study."
"This trial was designed to help physicians and their HIV-positive patients identify the best approach to treatment management," adds W
Source:NIH/National Institute of Allergy and Infectious Diseases