A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection

William G. Powderly, Dianne M. Finkelstein, Judith Feinberg, Peter Frame, Weili He, Charles Van Der Horst, Susan L. Koletar, M. Elaine Eyster, John Carey, Hetty Waskin, Thomas Hooton, Newton Hyslop, Stephen A. Spector, Samuel A. Bozzette

Research output: Contribution to journalArticle

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Abstract

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 person-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.

Original languageEnglish
Pages (from-to)700-705
Number of pages6
JournalNew England Journal of Medicine
Volume332
Issue number11
DOIs
StatePublished - Mar 16 1995
Externally publishedYes

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Clotrimazole
Mycoses
Fluconazole
Virus Diseases
HIV
Candidiasis
Cryptococcosis
Confidence Intervals
Cryptococcal Meningitis
Pneumocystis Pneumonia
CD4 Lymphocyte Count
Lymphocytes
Survival
Mortality

ASJC Scopus subject areas

  • Medicine(all)

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A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection. / Powderly, William G.; Finkelstein, Dianne M.; Feinberg, Judith; Frame, Peter; He, Weili; Van Der Horst, Charles; Koletar, Susan L.; Eyster, M. Elaine; Carey, John; Waskin, Hetty; Hooton, Thomas; Hyslop, Newton; Spector, Stephen A.; Bozzette, Samuel A.

In: New England Journal of Medicine, Vol. 332, No. 11, 16.03.1995, p. 700-705.

Research output: Contribution to journalArticle

Powderly, WG, Finkelstein, DM, Feinberg, J, Frame, P, He, W, Van Der Horst, C, Koletar, SL, Eyster, ME, Carey, J, Waskin, H, Hooton, T, Hyslop, N, Spector, SA & Bozzette, SA 1995, 'A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection', New England Journal of Medicine, vol. 332, no. 11, pp. 700-705. https://doi.org/10.1056/NEJM199503163321102
Powderly, William G. ; Finkelstein, Dianne M. ; Feinberg, Judith ; Frame, Peter ; He, Weili ; Van Der Horst, Charles ; Koletar, Susan L. ; Eyster, M. Elaine ; Carey, John ; Waskin, Hetty ; Hooton, Thomas ; Hyslop, Newton ; Spector, Stephen A. ; Bozzette, Samuel A. / A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection. In: New England Journal of Medicine. 1995 ; Vol. 332, No. 11. pp. 700-705.
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abstract = "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 person-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.",
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T1 - A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection

AU - Powderly, William G.

AU - Finkelstein, Dianne M.

AU - Feinberg, Judith

AU - Frame, Peter

AU - He, Weili

AU - Van Der Horst, Charles

AU - Koletar, Susan L.

AU - Eyster, M. Elaine

AU - Carey, John

AU - Waskin, Hetty

AU - Hooton, Thomas

AU - Hyslop, Newton

AU - Spector, Stephen A.

AU - Bozzette, Samuel A.

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N2 - 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 person-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.

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 person-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.

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