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Weekly Fluconazole for the Prevention of Mucosal Candidiasis in Women with HIV Infection: A Randomized, Double-Blind, Placebo-Controlled Trial

Paula Schuman, MD, MPH; Linnea Capps, MD, MPH; Grace Peng, MS; Jose Vazquez, MD; Wafaa El-Sadr, MD, MPH; Anne I. Goldman, PhD; Beverly Alston, MD; C. Lynn Besch, MD; Anita Vaughn, MD; Melanie A. Thompson, MD; Malik N. Cobb, RPA-C; Thomas Kerkering, MD; and Jack D. Sobel, MD
[+] Article, Author, and Disclosure Information

The Terry Beirn Community Programs for Clinical Research on AIDS. Acknowledgments: The authors thank Barbara Brizz, Carroll Child, Marjorie Dehlinger, Lawrence Deyton, Kathy Canady, Perry Eisman, Betsy Finley, and Dianne Murphy; the former DAIDS Medical Officer, Joyce Korvick; and the laboratory technologist, Kathleen M. Furness. Requests for Reprints: Paula Schuman, MD, MPH, Division of Infectious Diseases, Wayne State University, Harper Professional Building, 4160 John R Road, Suite 2140, Detroit, MI 48201. Current Author Addresses: Drs. Schuman, Vazquez, and Sobel: Division of Infectious Diseases, Wayne State University, Harper Professional Building, 4160 John R Road, Suite 2140, Detroit, MI 48201.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1997;126(9):689-696. doi:10.7326/0003-4819-126-9-199705010-00003
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Background: Candidiasis is a frequent complication of infection with the human immunodeficiency virus (HIV); however, few data exist about the natural history, prevention, and treatment of mucosal candidiasis in women.

Objective: To evaluate the safety and effectiveness of weekly fluconazole prophylaxis for mucosal candidiasis in women infected with HIV.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: 14 sites participating in the Community Programs for Clinical Research on AIDS (CPCRA).

Patients: 323 women with HIV infection and CD4+ cell counts of 300 cells/mm3 or less.

Intervention: 200 mg of fluconazole per week or placebo. Open-label fluconazole for candidiasis prophylaxis was permitted after two oropharyngeal or vaginal episodes or one esophageal episode.

Measurements: Development of mucosal candidiasis, clinical and in vitro resistance of Candida species to fluconazole, survival, and adverse events.

Results: After a median follow-up of 29 months, 72 of 162 patients receiving fluconazole and 93 of 161 patients receiving placebo had at least one episode of candidiasis (relative risk [RR], 0.56 [95% CI, 0.41 to 0.77]; P < 0.001). Weekly fluconazole was effective in preventing oropharyngeal candidiasis (RR, 0.50 [CI, 0.33 to 0.74]; P < 0.001) and vaginal candidiasis (RR, 0.64 [CI, 0.40 to 1.00]; P = 0.05) but not esophageal candidiasis (RR, 0.91 [CI, 0.48 to 1.72]; P > 0.2). Relative risks were similar for women who had a history of mucosal candidiasis (RR, 0.51 [CI, 0.35 to 0.75]) and those who did not (RR, 0.69 [CI, 0.35 to 1.34]). Absolute risk reduction for patients with a history of infection was 25.6 per 100 person-years, which is more than twice the reduction of 11.2 per 100 person-years seen in patients with no history of infection. This difference reflects the higher risk of patients who previously had an infection. Candida albicans was not usually resistant to fluconazole in vaginal specimens in clinical or in vitro settings; such resistance occurred in less than 5% of patients in each group.

Conclusions: Weekly fluconazole (200 mg) seems to be safe and effective in preventing oropharyngeal and vaginal candidiasis. This regimen has a useful role in the management of HIV-infected women who are at risk for recurrent mucosal candidiasis.

Figures

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Figure 1.
Kaplan-Meier estimates of the percentage of women who remained free of mucosal candidiasis and prophylaxis failure by treatment group.

Solid lines indicate patients receiving weekly fluconazole; dashed lines indicate patients receiving placebo. The number of patients at risk at 6, 12, 18, 24, and 30 months for first mucosal event are 127, 106, 91, 74, and 43 in the fluconazole group and 103, 77, 65, 56, and 27 in the placebo group, respectively. Corresponding numbers for prophylaxis failure are 143, 121, 107, 91, and 56 for the fluconazole group and 135, 108, 86, 75, and 42 for the placebo group, respectively.

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Figure 2.
Kaplan-Meier estimates of the percent of women who remained free of vaginal candidiasis by treatment group.

Solid line indicates patients receiving weekly fluconazole; dashed line indicates patients receiving placebo. The numbers of patients at risk at 6, 12, 18, 24, and 30 months for confirmed vaginal candidiasis are 143, 126, 113, 91, and 52 in the fluconazole group and 132, 108, 90, 72, and 40 in the placebo group, respectively.

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Grahic Jump Location
Figure 3.
Kaplan-Meier estimates of the percentage of women who remained free of oropharyngeal candidiasis by treatment group.

Solid line indicates patients receiving weekly fluconazole; dashed line indicates patients receiving placebo. The numbers of patients at risk at 6, 12, 18, 24, and 30 months for confirmed oropharyngeal candidiasis are 138, 119, 105, 87, and 56 for the fluconazole group and 123, 101, 87, 76, and 41 for the placebo group, respectively.

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