title: Risks and benefits of aerosolized pentamidine and cotrimoxazole in primary prophylaxis of Pneumocystis carinii pneumonia in HIV-1-infected patients: a two-year Italian multicentric randomized controlled trial. The Italian PCP Study Group.
abstract: We randomized 220 HIV-1-infected subjects to receive aerosolized pentamidine (300 mg/4 weeks) or orally trimethoprim-sulfamethoxazole (320-1600 mg/day) for primary prophylaxis of Pneumocystis carinii pneumonia (PCP), and evaluated PCP and toxoplasmic encephalitis (TE) occurrence and survival. Patients developing toxicity switched to the other regimen. Analysis was on intention-to-treat. At 1 year of study, we observed 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). After 2 years, no significant differences were observed: adjusted RR estimates for pentamidine vs. cotrimoxazole were 1.20 (95% CI, 0.33-4.37) for PCP (6 cases vs. 5), 1.23 (95% CI, 0.46-3.29) for TE (10 vs. 8) and 1.52 (95% CI, 0.83-2.79) for death (30 vs. 18). Crossovers were more frequent in the cotrimoxazole group (41 vs. 4, P < 0.001). Aerosolized pentamidine and cotrimoxazole were equally effective in preventing PCP, and no major differences were observed in TE occurrence and survival after 2 years follow-up.
authors.affiliation: Institute of Internal Medicine, Infectious Diseases and Immunopathology, University of Milan, Italy.
authors.forename: G P
authors.initials: GP
authors.lastname: Rizzardi
authors.forename: A
authors.initials: A
authors.lastname: Lazzarin
authors.forename: M
authors.initials: M
authors.lastname: Musicco
authors.forename: D
authors.initials: D
authors.lastname: Frigerio
authors.forename: M
authors.initials: M
authors.lastname: Maillard
authors.forename: M
authors.initials: M
authors.lastname: Lucchini
authors.forename: M
authors.initials: M
authors.lastname: Moroni
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control*; D000328:Adult; D000336:Aerosols; D005260:Female; D015497:HIV-1; D006801:Humans; D008297:Male; D010419:Pentamidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011020:Pneumonia, Pneumocystis / Q000517:prevention & control*; D016781:Toxoplasmosis, Cerebral / Q000517:prevention & control*; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000336:Aerosols; D010419:Pentamidine; D015662:Trimethoprim, Sulfamethoxazole Drug Combination