Trimetrexate with leucovorin versus trimethoprim-sulfamethoxazole for moderate to severe episodes of Pneumocystis carinii pneumonia in patients with AIDS: a prospective, controlled multicenter investigation of the AIDS Clinical Trials Group Protocol 029/031.

Abstract	Trimetrexate is a powerful inhibitor of the dihydrofolate reductase of Pneumocystis carinii. AIDS patients (n = 215) with moderate to severe P. carinii pneumonia were enrolled in a double-blind study of trimetrexate plus leucovorin versus trimethoprim-sulfamethoxazole (TMP-SMZ) for 21 days. By study day 10, study therapy failed because of lack of efficacy in 16% of patients assigned to TMP-SMZ and 27% assigned to trimetrexate (P = .064), and the PAO2-PaO2 improved significantly faster with TMP-SMZ. By study day 21, failure rates were 20% with TMP-SMZ and 38% with trimetrexate (P = .008), with respective mortality rates of 12% and 20% (P = .088). By study day 49, the difference in mortality (16% vs. 31%) was significant (P = .028). The cumulative incidence of serious and treatment-terminating adverse events including hematologic toxicities was less with trimetrexate (P < .001). Thus, trimetrexate plus leucovorin was effective, albeit inferior to TMP-SMZ, for moderately severe P. carinii pneumonia but was better tolerated than TMP-SMZ.
Authors	F R Sattler, P Frame, R Davis, L Nichols, B Shelton, B Akil, R Baughman, C Hughlett, W Weiss, C T Boylen
Journal	The Journal of infectious diseases (J Infect Dis) Vol. 170 Issue 1 Pg. 165-72 (Jul 1994) ISSN: 0022-1899 [Print] United States
PMID	8014493 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References	Trimethoprim Sulfamethoxazole Leucovorin Trimetrexate
Topics	AIDS-Related Opportunistic Infections (drug therapy, mortality) Adolescent Adult Child Clinical Protocols Double-Blind Method Drug Therapy, Combination Female Humans Leucovorin (adverse effects, therapeutic use) Male Middle Aged Multicenter Studies as Topic Pneumonia, Pneumocystis (complications, drug therapy, mortality) Prospective Studies Sulfamethoxazole (adverse effects, therapeutic use) Treatment Outcome Trimethoprim (adverse effects, therapeutic use) Trimetrexate (adverse effects, therapeutic use)

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