SMART Studies Two HAART Strategies for HIV

BETHESDA, Maryland—A long-term study to determine which of two common strategies is better for treating HIV-infected individuals was initiated in January, as 21 US centers and several Australian sites began enrolling the first 1,000 patients. Participants in the SMART trial (Strategies for Management of Anti-Retroviral Therapies) are randomized to receive immediate, aggressive antiretroviral therapy ("hit-hard-early") or no HIV drugs until CD4+ T-cell counts fall below 250 cells/µL ("go-slow").

If first-year results prove the feasibility of a full study, researchers will enroll another 5,000 patients over 3 years. They expect to follow the 6,000 patients for between 6 and 9 years. The Community Programs for Clinical Research on AIDS, a network funded by NIAID, will conduct the study.

Aggressive drug treatment for HIV and AIDS patients—commonly referred to as HAART (highly active antiretroviral therapy)—and other advances introduced since the mid-1990s are credited with prolonging the lives of many infected individuals. However, the regimen of powerful drugs that make up the HAART "cocktail" is expensive, difficult to follow, and frequently causes serious side effects after prolonged use.

"There are many unanswered questions about the most appropriate use of antiviral therapy," said Karin Klingman, MD, of the National Institute of Allergy and Infectious Diseases. "We simply do not know when is the best time to begin therapy after infection or to switch from one treatment to another."

Patients randomized to the "hit-hard-early" group will immediately go on medications used to suppress HIV levels to low or undetectable levels. The study protocol does not limit the types or the number of HIV drugs that can be used. Those in the "go-slow" arm must agree not to take antiviral drugs until their CD4+ cell counts sink below 250 cells/µL, and then cease taking the drugs once their cell count rises above 350 cells/µL.

Enrollment is open to HIV-positive males and females who are at least 13 years old and have a CD4+ cell count of more than 350 cells/µL within 45 days before randomization. For more information, go to www.actis.org.