International HIV/AIDS Trial Finds Continuous Antiretroviral Therapy Superior to Episodic Therapy
HIV AIDS Trial
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), today announced that enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment guided by levels of CD4+ cells has been stopped. 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). The DSMB, charged with regularly evaluating data and safety issues during the multi-year trial, conducted a review of the interim study data in early January.
The trial, known as Strategies for Management of Anti-Retroviral Therapy, or SMART, was designed to determine which of two different HIV treatment strategies would result in greater overall clinical benefit. HIV-positive volunteers were assigned at random to either a viral suppression strategy, in which antiretroviral therapy (ART) was taken on an ongoing basis to suppress HIV viral load; or a drug conservation strategy, in which ART was started only when the levels of key immune cells, called CD4+ cells, dropped below 250 cells per cubic millimeter (mm3). Volunteers in the drug conservation group were taken off ART