RISKS AND BENEFITS OF AEROSOLIZED PENTAMIDINE AND COTRIMOXAZOLE IN PRIMARY PROPHYLAXIS OF PNEUMOCYSTIS-CARINII PNEUMONIA IN HIV-1-INFECTED PATIENTS - A 2-YEAR ITALIAN MULTICENTRIC RANDOMIZED CONTROLLED TRIAL

We randomized 220 HIV-1 infected subjects to receive aerosolized penta midine (300 mg/4 weeks) or orally trimethoprim-sulfamethoxazole (320-1 600 mg/day for primary prophylaxis of Pneumocystis carinii pneumonia ( PCP), and evaluated PCP and toxoplasmic encephalitis (TE) occurrence a nd survival. Patients developing toxicity switched to the other regime n. Analysis was on intention-to-treat. At 1 year of study, were observ ed in the pentamidine group a non-significant excess of PCP (4 vs. 1) and TE (7 vs. 3), and a significant increased death rate (15 vs. 2). A fter 2 years, no significant differences were observed: adjusted RR es timates for pentamidine vs. cotrimoxazole were 1.20 (95% CL, 0.33-4.37 ) for PCP (6 cases vs. 5), 1.23 (95% CL, 0.46-3.29) for TE (10 vs. 8) and 1.52 (95% CL, 0.83-2-79) for death (30 vs. 18). Crossovers were mo re frequent in the cotrimoxazole group (41 vs. 4, P<0.001). Aerosolize d pentamidine and cotrimoxazole were equally effective in preventing P CP, and no major differences were observed in TE occurrence and surviv al after 2 years follow-up.