       Document 0554
 DOCN  M9550554
 TI    A randomized trial of three antipneumocystis agents in patients with
       advanced human immunodeficiency virus infection. NIAID AIDS Clinical
       Trials Group [see comments]
 DT    9505
 AU    Bozzette SA; Finkelstein DM; Spector SA; Frame P; Powderly WG; He W;
       Phillips L; Craven D; van der Horst C; Feinberg J; University of
       California, San Diego, La Jolla.
 SO    N Engl J Med. 1995 Mar 16;332(11):693-9. Unique Identifier : AIDSLINE
       MED/95157587
 CM    Comment in: N Engl J Med 1995 Mar 16;332(11):739-40
 AB    BACKGROUND. We evaluated the effectiveness of three treatment strategies
       for the prevention of a first episode of Pneumocystis carinii pneumonia
       in patients infected with the human immunodeficiency virus (HIV).
       METHODS. In an open-label trial, 843 patients with HIV infection and
       fewer than 200 CD4+ cells per cubic millimeter received zidovudine plus
       one of three randomly assigned prophylactic agents, beginning with
       trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine and
       followed by a defined sequence of other drugs to be used in cases of
       intolerance. RESULTS. The estimated 36-month cumulative risks of P.
       carinii pneumonia were 18 percent, 17 percent, and 21 percent in the
       trimethoprim-sulfamethoxazole, dapsone, and aerosolized-pentamidine
       groups, respectively (P = 0.22). The difference in risk among treatment
       strategies was negligible in patients entering the study with 100 or
       more CD4+ lymphocytes per cubic millimeter. In those entering with fewer
       than 100 CD4+ cells per cubic millimeter, the risk was 33 percent with
       aerosolized pentamidine, as compared with 19 percent with
       trimethoprim-sulfamethoxazole and 22 percent with dapsone (P = 0.04).
       The lowest failure rates occurred in patients receiving
       trimethoprim-sulfamethoxazole, and failures were more common with 50 mg
       of dapsone than with 100 mg. Toxoplasmosis developed in less than 3
       percent of patients. Of the patients assigned to the two systemic
       therapies, only 23 percent were receiving their assigned drug and dose
       when they completed the study. The median survival was approximately 39
       months in all three groups, and the mortality attributable to P. carinii
       pneumonia was only 1 percent. CONCLUSIONS. In patients with advanced HIV
       infection, the three treatment strategies we examined have similar
       effectiveness in preventing P. carinii pneumonia. Strategies that start
       with trimethoprim-sulfamethoxazole or with high-dose dapsone, rather
       than aerosolized pentamidine, are superior in patients with fewer than
       100 CD4+ lymphocytes per cubic millimeter.
 DE    Administration, Oral  Adult  Aerosols  AIDS-Related Opportunistic
       Infections/IMMUNOLOGY/MORTALITY/  *PREVENTION & CONTROL  Comparative
       Study  CD4 Lymphocyte Count  Dapsone/ADVERSE EFFECTS/*THERAPEUTIC USE
       Drug Tolerance  Female  Human  Male  Patient Compliance
       Pentamidine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       Pneumonia, Pneumocystis carinii/*PREVENTION & CONTROL  Support, U.S.
       Gov't, P.H.S.  Trimethoprim-Sulfamethoxazole Combination/*THERAPEUTIC
       USE  CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY  RANDOMIZED
       CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

