AEROSOLIZED PENTAMIDINE FOR PRIMARY PROPHYLAXIS OF PNEUMOCYSTIS-CARINII PNEUMONIA - A CONTROLLED, RANDOMIZED TRIAL

The objective was to assess the efficacy of a biweekly dose of 60 mg a erosolized pentamidine (AP) for primary prophylaxis (PP) of Pneumocyst is carinii pneumonia (PCP) and the impact of prophylaxis on survival i n HIV-infected patients. Participants were AIDS patients with no histo ry of PCP, patients with a CD4 count less-than-or-equal-to 0.200 x 10( 9)/L, or patients belonging to the CDC group IVC2, irrespective of CD4 count. It was an open, randomized, controlled trial. Patients were as signed to receive AP, 60 mg biweekly via a System 22 nebulizer, or to a control group not receiving any prophylaxis. Incidence curves for PC P and survival were generated using the Kaplan-Meier method, stratifie d by treatment group, and compared using the log-rank test. Data were analyzed according to intention to treat. There were 15 cases of PCP a mong 105 patients in the AP group and 32 cases among 104 patients in t he control group. The cumulative incidence of PCP by 18 months was 13% (95% CI 5-21%) in the AP group and 30% (95% CI 18-41%) in the control group, (p = 0.002). During the study period 19 patients (18%) in the AP group died and 24 patients (23%) in the control group (NS; p = 0.28 ). We conclude that a biweekly dose of 60 mg AP is efficient as primar y PCP prophylaxis when a System 22 nebulizer is used. There was, howev er, no difference in survival between the groups, suggesting that AP h as an impact on morbidity only.