A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome. AIDS Clinical Trials Group Protocol 021.

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

N Engl J Med. 1992 Dec 24;327(26):1842-8. Unique Identifier : AIDSLINE MED/93078813
Hardy WD; Feinberg J; Finkelstein DM; Power ME; He W; Kaczka C; Frame PT; Holmes M; Waskin H; Fass RJ; et al; Department of Medicine, University of California, Los Angeles.

Abstract: BACKGROUND. Pneumocystis carinii pneumonia (PCP) continues to be the most common index diagnosis in the acquired immunodeficiency syndrome (AIDS), but it is not clear which of several available agents is the most effective in preventing a recurrence of PCP. METHODS. We conducted a comparative, open-label trial in 310 adults with AIDS who had recently recovered from an initial episode of PCP and had no treatment-limiting toxic effects of trimethoprim-sulfamethoxazole or pentamidine. All the patients were treated with zidovudine and were randomly assigned to receive either 800 mg of sulfamethoxazole and 160 mg of trimethoprim once daily or 300 mg of aerosolized pentamidine administered every four weeks by jet nebulizer. The participants were followed for a median of 17.4 months. RESULTS. In the trimethoprim-sulfamethoxazole group (n = 154) there were 14 recurrences of PCP, as compared with 36 recurrences (including 1 extrapulmonary recurrence) in the aerosolized-pentamidine group (n = 156). The estimated recurrence rates at 18 months were 11.4 percent with trimethoprim-sulfamethoxazole and 27.6 percent with pentamidine (P < 0.001). The risk of a recurrence (adjusted for initial CD4 cell count) was 3.25 times higher in the pentamidine group (P < 0.001, 95 percent confidence interval, 1.72 to 6.16). There were no significant differences between the groups in survival or in hematologic or hepatic toxicity. Crossovers from trimethoprim-sulfamethoxazole to aerosolized pentamidine were more common than the reverse (27 vs. 4 percent), partly because of the study protocols for the management of leukopenia. There were 19 serious bacterial infections in the trimethoprim-sulfamethoxazole group and 38 in the pentamidine group. The time to a first bacterial infection was significantly greater for those assigned to trimethoprim-sulfamethoxazole (P = 0.017). CONCLUSIONS. In patients with AIDS who are receiving zidovudine, trimethoprim-sulfamethoxazole is more effective than aerosolized pentamidine in conventional doses for the prevention of recurrent pneumocystis infection.

Keywords: Aerosols AIDS-Related Opportunistic Infections/*PREVENTION & CONTROL Comparative Study Female Follow-Up Studies Human Male Pentamidine/*ADMINISTRATION & DOSAGE/TOXICITY Pneumonia, Pneumocystis carinii/*PREVENTION & CONTROL Random Allocation Recurrence Support, U.S. Gov't, P.H.S. Survival Rate Trimethoprim-Sulfamethoxazole Combination/*ADMINISTRATION & DOSAGE/TOXICITY Zidovudine/THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL
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