NIAID Halts International HIV/AIDS Strategic Management of Anti-Retroviral Therapy (SMART) Trial

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced that it has stopped enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment guided by levels of CD4+ cells. This trial found that continuous antiretroviral therapy is superior to episodic therapy. However, enrollment was stopped because those patients receiving episodic therapy had twice the risk of disease progression (the development of clinical AIDS or death), the major outcome of the study.

NIAID made the decision to halt enrollment in collaboration with the study’s Executive Committee and following a recommendation received from an independent Data and Safety Monitoring Board (DSMB). To read the full news release on this trial go to: http://aidsinfo.nih.gov/ContentFiles/SMART_trial_ends_early.pdf. To view the Questions and Answers document that NIAID has created about this SMART trial go to: http://aidsinfo.nih.gov/ContentFiles/SMART_trial_ends_early_QA.pdf.