A large, long-term, randomized trial comparing two antiretroviral treatment strategies. Patients were randomised equally (1:1) to either the Drug Conservation (control) group or the Viral Suppression (experimental) group. The primary endpoint was clinical HIV-related disease progression or death.
The study was opened for enrolment in the US and Australia in January 2002, and in April 2004 addition of sites in Europe, Asia, South and North America began. When enrolment was stopped 5,472 patients from 318 sites on 6 continents had been enrolled.
Enrolment was stopped on 11 January 2006 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. Follow-up of study particpants was continued until July 11, 2007.
For details about the trial go to the INSIGHT website. For a complete list of INSIGHT publications also see the INSIGHT website.
The EudraCT http://eudract.emea.eu.int/ number for SMART is 2004-000441-38.
For additional information about or help in using the EudraCT number please contact CHIP.