What were the rationale and primary objectives of the SMART trial?
Widespread use of ART in economically developed countries has resulted in a significant decline in HIV-related illness and death. However, ART effectiveness may wane over time as the virus becomes resistant to drugs. There are also short- and long-term toxicities, as well as cost and quality-of-life issues, associated with lifelong ART. Therefore, a randomized clinical trial was implemented comparing the use of CD4+ cell-guided episodic ART (DC strategy) with continuous ART (VS strategy). The SMART trial was designed to compare the DC strategy with the VS strategy for progression to AIDS or death over a minimum follow-up period of 6 years for each patient. It was hypothesized that the DC strategy would result in lower rates of disease progression and serious toxicities as compared to the VS strategy in the planned follow-up period ranging from 6 to 9 years. 3. Who is conducting this study and where? The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA, http://www.cpc
