The independent drug safety and monitoring board of the ACTG 1571 study into three alternative once-daily antiretroviral combinations has prematurely stopped one of the study arms.
Interim results from the study, which involves patients taking anti-HIV treatment for the first time, showed that a once-daily antiretroviral combination of atazanavir, FTC and enteric-coated ddI (ddI-EC) was associated with poorer control of HIV. Patients taking this regimen will be switched to one of the other drug combinations being investigated in the study.
Enrollment to the study started in July 2007 and its primary focus is patients in low- and middle-income countries. Patients were randomised to either receive AZT, 3TC and efavirenz, regarded as the standard of care, or two alternative once-daily antiretroviral combinations. The alternative combinations were FTC, tenofovir and efavirenz, or atazanavir, FTC and ddI-EC. The study is titled “Evaluation of once-daily PI and NNRTI regimens as initial HIV therapy in individuals from resource-limited settings.”
Conclusive evidence was presented to the study’s independent over-sight board that patients who were treated with atazanavir, FTC and ddI-EC were less likely to achieve an undetectable viral load. They therefore took the decision to terminate this arm of the study. The US National Institute of Allergy and Infectious Diseases, which is overseeing the study, accepted this recommendation and had stopped this arm of the study.
Patients who were receiving atazanavir, FTC and ddI-EC are being advised to contract their study doctor to discuss which of the other two anti-HIV treatment combinations they should take.