ACTG (AIDS Clinical Trials Group) 384: A strategy trial comparing consecutive treatments for HIV-1

ACTG (AIDS Clinical Trials Group) 384 is designed to evaluate different str ategies for antiretroviral treatment in HIV-1-infected individuals with no previous exposure to antiretroviral treatment. The study is a randomized, p artially double-blinded, controlled trial with 980 subjects at 81 centers i n the United States and Italy. The study has a factorial design that addres ses the following scientific questions: (1) Does the best initial choice of therapy include both a protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) in a four-drug combination with nucleoside analogue (NRTI) drugs, or should these agents be used sequentially in three -drug combinations?; (2) Which sequence is best in a three-drug regimen-PI followed by NNRTI or NNRTI followed by PI ?; (3) Which is the best sequence of dual NRTI combinations-zidovudine plus lamivudine followed by didanosin e plus stavudine, or the converse? Subjects in the three-drug combination a rms are offered a salvage regimen after failure of their second regimen; su bjects in the four-drug combination arm are offered a salvage regimen after failure of their first regimen. The primary endpoint of the study is the t ime until salvage; secondary endpoints include time to virological failure and time to toxicity related discontinuation of therapy. A Division of AIDS Data and Safety Monitoring Board will review the trial for safety and effi cacy. (C) Elsevier Science Inc. 2001.