4th Conference on Retroviruses and Opportunistic Infections


Washington, DC - January 22-26, 1997

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ACTG 268 trial - gradual initiation of trimethoprim/sulfamethoxazole (T/S) as primary prophylaxis for Pneumocystis carinii pneumonia (PCP).

Conf Retroviruses Opportunistic Infect 1997 Jan 22-26; 4th:65 (abstract no. 2)

Para MF, Dohn M, Frame P, Becker S, Finkelstein D, Walawander A; Ohio State Univ, Columbus, OH.

Objective: T/S is recognized as the superior agent for PCP prophylaxis, but a high incidence of adverse drug reactions limits its use. We tested the hypothesis that gradual initiation of T/S prophylaxis might reduce the incidence of toxicities compared to initiating double strength tablets.

Method: ACTG 268 was a randomized double blind, placebo controlled 2 arm trial of T/S for PCP prophylaxis in HIV+subjects. Subjects received T/S ds tablets or a gradually increasing dose of T/S suspension (8 mg TMP/40 mg SMX per mL). The suspension dosing was 1 cc daily for the first 3 days, then 2 cc qd x 3, then 5cc qd x 3, then 10cc qd x 3, then 20 cc/d until the week 2 visit. During the first 2 weeks subjects also received a matching placebo tablet/suspension. At 2 wk visit all subjects received T/S ds tablets for the next 10 wks. Drug was discontinued if the patient had significant adverse reactions or requested to have therapy stopped.

Findings: 377 patients enrolled. 86% were men, 61% white, 29% African American, 8% Hispanic. The mean CD4 count = 167. There were no differences in baseline characteristics between arms. Significantly fewer subjects discontinued T/S when it was initiated gradually than when initiated as ds tablets (p is less than .001), but the time to grade 2 or greater toxicities was similar in both arms. Final analysis is underway.

Conclusion: Gradual initiation of T/S for 10 PCP prophylaxis reduces the incidence of treatment limiting adverse effects in the first 12 weeks.

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