Document 0553
 DOCN  M9550553
 TI    A randomized trial comparing fluconazole with clotrimazole troches for
       the prevention of fungal infections in patients with advanced human
       immunodeficiency virus infection. NIAID AIDS Clinical Trials Group [see
       comments]
 DT    9505
 AU    Powderly WG; Finkelstein D; Feinberg J; Frame P; He W; van der Horst C;
       Koletar SL; Eyster ME; Carey J; Waskin H; et al; Washington University
       School of Medicine, St. Louis.
 SO    N Engl J Med. 1995 Mar 16;332(11):700-5. Unique Identifier : AIDSLINE
       MED/95157588
 CM    Comment in: N Engl J Med 1995 Mar 16;332(11):739-40
 AB    BACKGROUND. Cryptococcal meningitis and other serious fungal infections
       are common complications in patients infected with the human
       immunodeficiency virus (HIV). Fluconazole is effective for long-term
       suppression of many fungal infections, but its effectiveness as primary
       prophylaxis had not been adequately evaluated. METHODS. We conducted a
       prospective, randomized trial that compared fluconazole (200 mg per day)
       with clotrimazole troches (10 mg taken five times daily) in patients who
       were also participating in a randomized trial of primary prophylaxis for
       Pneumocystis carinii pneumonia. RESULTS. After a median follow-up of 35
       months, invasive fungal infections had developed in 4.1 percent of the
       patients in the fluconazole group (9 of 217) and in 10.9 percent of
       those in the clotrimazole group (23 of 211; relative hazard, as adjusted
       for the CD4+ count, 3.3; 95 percent confidence interval, 1.5 to 7.6). Of
       the 32 invasive fungal infections, 17 were cryptococcosis (2 in the
       fluconazole group and 15 in the clotrimazole group; adjusted relative
       hazard, 8.5; 95 percent confidence interval, 1.9 to 37.6). The benefit
       of fluconazole was greater for the patients with 50 or fewer CD4+ cells
       per cubic millimeter than for the patients with higher counts.
       Fluconazole was also effective in preventing esophageal candidiasis
       (adjusted relative hazard, 5.8; 95 percent confidence interval, 1.7 to
       20.0; P = 0.004) and confirmed and presumed oropharyngeal candidiasis
       (5.7 and 38.1 cases per 100 years of follow-up in the fluconazole and
       clotrimazole groups, respectively; P < 0.001). Survival was similar in
       the two groups. CONCLUSIONS. Fluconazole taken prophylactically reduces
       the frequency of cryptococcosis, esophageal candidiasis, and superficial
       fungal infections in HIV-infected patients, especially those with 50 or
       fewer CD4+ lymphocytes per cubic millimeter, but the drug does not
       reduce overall mortality.
 DE    Adult  AIDS-Related Opportunistic Infections/IMMUNOLOGY/*PREVENTION &
       CONTROL  Clotrimazole/*THERAPEUTIC USE  Comparative Study  Confidence
       Intervals  CD4 Lymphocyte Count  Female  Fluconazole/*THERAPEUTIC USE
       Follow-Up Studies  Human  Male  Mycoses/*PREVENTION & CONTROL
       Proportional Hazards Models  Prospective Studies  Support, Non-U.S.
       Gov't  Support, U.S. Gov't, P.H.S.  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).