A Randomized Trial Comparing Fluconazole with Clotrimazole Troches for the Prevention of Fungal Infections in Patients with Advanced Human Immunodeficiency Virus Infection
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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.
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Long-term suppressive therapy with fluconazole is effective in prevention of oropharyngeal candidiasis in patients with AIDS and patients with cancer.
“Long-term suppressive therapy with fluconazole is effective in the prevention of oropharyngeal candidiasis in patients with AIDS [32,[261][262][263] and patients with cancer [264].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [261]
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References 17 · Cited by 318
Research works printed but not linked: 3
- Leoung GS, Feigal DW, Montgomery AB, et al. Aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia: the San Francisco community prophylaxis trial. N Engl J Med 1990;323:769-75.
- Chuck SL, Sande MA. Infections with Cryptococcus neoformans in the ac- quired immunodeficiency syndrome. N Engl J Med 1989;321:794-9.
- Wheat LJ, Mawhinney S, Hafner R, et al. Fluconazole treatment for histo- plasmosis in AIDS: prospective multicenter noncomparative trial. In: Pro- gram and abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy, Orlando, Fla., Oct. 4-7, 1994. Washington, D.C.: American Society for Microbiology, 1994:214. abstract.
- Authors
- Powderly, W. G., Finkelstein, D. M., Feinberg, J., Frame, P., He, W., van der Horst, C., Koletar, S. L., Eyster, M. E., Carey, J., Waskin, H., Hooton, T. M., Hyslop, N., Spector, S. A., & Bozzette, S. A.
- Affiliations
- Washington University in St. Louis (US)
- Harvard University (US)
- Johns Hopkins University (US)
- University of Cincinnati (US)
- The Ohio State University (US)
- Pennsylvania State University (US)
- Case Western Reserve University (US)
- Duke University (US)
- University of Washington (US)
- Tulane University (US)
- University of California San Diego (US)
- RAND Corporation (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1995-03-16
- Volume
- 332
- Issue
- 11
- Pages
- 700-705
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2339763729
- Cited by
- 318
- References
- 17
- Citations by year
- 2025: 1 · 2024: 1 · 2022: 3 · 2021: 3 · 2020: 1 · 2019: 5 · 2018: 5 · 2017: 2 · 2016: 3 · 2015: 4 · 2014: 7 · 2013: 10 · 2012: 10
- FWCI
- 28.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs
- Pfizer
- Ohio State University
- Memorial Sloan-Kettering Cancer Center
- Northwestern University
- Syracuse University
- University of Minnesota
- University of Washington
- Tulane University
- Johns Hopkins University
- University of Cincinnati
- Case Western Reserve University
- Louisiana State University
- University of California, Los Angeles
- University of California, San Diego
- University of California, San Francisco
- Penn State College of Medicine
- National Institute of Allergy and Infectious Diseases
- National Center for Research Resources
- School of Medicine, University of North Carolina at Chapel Hill
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
- Health Sciences › Medicine › Epidemiology › Pneumocystis jirovecii pneumonia detection and treatment
- Keywords
- fluconazole, antifungal prophylaxis, invasive fungal infections, cryptococcosis, cryptococcal meningitis, esophageal candidiasis, oropharyngeal candidiasis, HIV infection, CD4 count, survival
- MeSH terms
- Adult, Clotrimazole, Female, Follow-Up Studies, Humans, Male, Mycoses, Prospective Studies, Fluconazole, Confidence Intervals, Proportional Hazards Models, AIDS-Related Opportunistic Infections, CD4 Lymphocyte Count
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