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ACTG 081 is a phase III open label comparison of ZDV plus trimethroprim sulfamethoxazole (TS) or aerosolized pentamidine (AP), or dapsone for prevention of PCP in patients with no prior PCP, and CD4 counts below 200. This analysis is based on 842 patients accrued between May 1989 and June 1990. Median follow-up is 39.1 months. The primary endpoint of this trial, in the absence of unexpected mortality differences, was the time to initial PCP. One hundred thirty-seven (16.3%) patients developed PCP during the study. The participants randomized to trimethoprin sulfamethoxazole and dapsone experienced a delay in the time to PCP, compared to those assigned to AP although the differences were not statistically significant. Patients on AP experienced significantly lower rates of severe hematologic complications (granulocytes < 750/mm3, p = .01). A significantly higher proportion of severe or worse fever (p=.02) and rash (p<.0001) were experienced by patients on dapsone and TS than on AP.