TreatmentUpdate41: Vol. 4, No. 1 - March, 1993
Sean Hosein

10 subjects developed toxo; 4 on B/S and 6 on AP. The differences in numbers were too small to be significant. Please see the trial summary section for more information on toxo.

Bacterial Infections

Subjects given B/S took significantly longer to develop bacterial infections and had fewer of these infections compared to subjects given AP.

MAC

(Mycobacterium avium complex). Over 60% of MAC infections developed in subjects who were receiving AP.

Yeast Infections

Fungal infections were common in both arms of the study. Use of B/S or AP did not appear to cause these infections.

Results--Survival

Ninety subjects died during the study; 43 were on B/S and 47 on AP. At least half of those given B/S lived for 26 months. For the group receiving AP the equivalent figure was 23 months. Approximately 6% of deaths in the study were due to PCP.

Toxicity

Roughly equal proportions of subjects in each of the study arms developed drug toxicity. Symptoms of drug toxicity included the following; "severe [weakness], severe abdominal pain, and severe rash." More subjects assigned to the B/S arm switched to AP than did subjects assigned to the AP arm who switched to the B/S arm.

Trial Summary

Analysis of the data shows that subjects given B/S clearly had better protection against PCP than did those given AP. Although 4 subjects who received B/S developed toxo, only one of these subjects was actually taking B/S at the time symptoms of toxo appeared. The 3 remaining subjects had been switched from B/S to AP before they developed toxo. According to the study doctors, "only 1 of 10 participants in whom [toxol developed was actually receiving [B/S] at the time of diagnosis." About 70% of subjects who did not have life-threatening reactions to B/ S in the past were able to tolerate preventative doses of the drug.

References

1. Hardy WD, Feinberg J, Finkelstein DM, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the Acquired ImmuneDeficiency Syndrome (AIDS): AIDS Clinical Trials Group protocol 021. New England Journal of Medicine 1992:327(26):1842-1848.

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