ACTG 175: Randomized, Double-Blind Phase 2/3 Trial of Monotherapy vs. CombinationTherapy with Nucleoside Analogues in HIV-Infected Persons with CD4 Cells >/=200 and

摘要

ACTG 175 was a randomized double-blind, placebo-controlled trial to comparemonotherapy with zidovudine or didanosine with combination therapy with zidovudine and didanosine or zidovudine and zalcitabine in HIV-1-infected subjects with CD4 cell counts between 200 and 500 per cubic millimter. Patients were recruited from 43 AID Clinical Trials United and 9 National Hemophilia Foundation sites in the United States and Puerto Rico, and randomly assigned to one of the four treatment groups. Subjects were examined at weeks 2, 4, and 8, and then every 12 weeks thereafter. The primary endpoint was a greater than or equal 50 prevent decline in the CD4 cell count, development of AIDs, or death. Progression of the primary endpoint was more frequent with zidovudine alonge (32 percent) than with zidovudine plus didanosine (18 percent). The relative hazard ratios for progression to an AID-defining event or dealth were 0.64 for zidovudine plus didanosine, as compared with zidovudine alonge, 0.77 for zidovudine plus zalcitabine, and 0.69 for didanosine alone.