14717
document
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 . 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 .
14718
Intervention_Pharmacological
trimethoprim-sulfamethoxazole
14719
Intervention_Pharmacological
aerosolized pentamidine
14720
Intervention_Pharmacological
trimethoprim-sulfamethoxazole
14721
Intervention_Pharmacological
pentamidine
14722
Intervention_Pharmacological
zidovudine
14723
Intervention_Pharmacological
800 mg of sulfamethoxazole and 160 mg of trimethoprim
14724
Intervention_Pharmacological
300 mg of aerosolized pentamidine
14725
Intervention_Pharmacological
jet nebulizer
14726
Intervention_Pharmacological
trimethoprim-sulfamethoxazole
14727
Intervention_Pharmacological
trimethoprim-sulfamethoxazole
14728
Intervention_Pharmacological
pentamidine
14729
Intervention_Pharmacological
pentamidine
14730
Intervention_Pharmacological
trimethoprim-sulfamethoxazole
14731
Intervention_Pharmacological
pentamidine
14732
Intervention_Pharmacological
zidovudine
14733
Intervention_Pharmacological
trimethoprim-sulfamethoxazole
14734
Intervention_Pharmacological
aerosolized pentamidine
14735
Outcome_Physical
preventing a recurrence of PCP
14736
Outcome_Physical
recurrences of PCP
14737
Outcome_Physical
recurrence rates
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Outcome_Physical
recurrence
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Outcome_Mortality
survival
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Outcome_Adverse-effects
hematologic or hepatic toxicity .
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Outcome_Physical
bacterial infections
14742
Outcome_Physical
time to a first bacterial infection
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Outcome_Physical
prevention of recurrent pneumocystis infection
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Participant_Condition
acquired immunodeficiency syndrome
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Participant_Sample-size
310
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Participant_Age
adults
14747
Participant_Condition
AIDS
14748
Participant_Condition
recently recovered from an initial episode of PCP
14749
Participant_Condition
no treatment-limiting toxic effects of trimethoprim-sulfamethoxazole or pentamidine
14750
Participant_Condition
AIDS