A MULTICENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF ADJUNCTIVE CORTICOSTEROIDS IN THE TREATMENT OF PNEUMOCYSTIS-CARINII PNEUMONIA COMPLICATING THE ACQUIRED-IMMUNE-DEFICIENCY-SYNDROME

A multicenter placebo-controlled trial of early short-term high-dose m ethylprednisolone enrolled 78 patients with moderate to severe Pneumoc ystis carinii pneumonia (PCP) complicating HIV infection. The mean pre ssure of oxygen (Po-2) at study entry was 55 mm Hg for the 71 patients who had blood gases monitored while breathing room air. Patients were randomized to receive methylprednisolone (40 mg) or placebo parentera lly twice daily for 10 days, and the first dose of study medication wa s given within 24 h of the first dose of antimicrobial therapy for PCP . The primary end point included death, need for mechanical ventilatio n for >6 days, or a partial Po-2 <70 mm Hg while breathing room air 10 days after initiation of treatment. There was no statistically signif icant difference in the primary end point between patients randomized to corticosteroid (CS) or placebo (PL) (p = 0.522; 95% CI = -0.30, 0.1 6). The incidence of superinfections during therapy or of other HIV-as sociated infections or malignancies in the 6 months following treatmen t for PCP was not significantly different between the two groups. More patients randomized to placebo had to discontinue treatment with trim ethoprim-sulfamethoxazole because of hypersensitivity than those rando mized to corticosteroids (p = 0.039). We conclude that addition of cor ticosteroids does not significantly affect the outcome of PCP in patie nts with HIV and a Po-2 <70 mm Hg on room air at presentation but lowe rs the incidence of hypersensitivity reactions to trimethoprim-sulfame thoxazole.