A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

Summary

To compare the efficacy of fluconazole versus placebo for the prevention of Candida esophagitis and vaginal/oropharyngeal candidiasis, including a comparison of the development of clinical resistance. Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women. An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons.

Timeline

Start

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Primary completion

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Completion

1995-12

Publications

• Background Schuman P, Capps L, Peng G, Vazquez J, el-Sadr W, Goldman AI, Alston B, Besch CL, Vaughn A, Thompson MA, Cobb MN, Kerkering T, Sobel JD. Weekly fluconazole for the prevention of mucosal candidiasis in women with HIV infection. A randomized, double-blind, placebo-controlled trial. Terry Beirn Community Programs for Clinical Research on AIDS. Ann Intern Med. 1997 May 1;126(9):689-96. doi: 10.7326/0003-4819-126-9-199705010-00003.
• Background Capps L, Peng G, Doyle M, El-Sadr W, Neaton JD. Sexually transmitted infections in women infected with the human immunodeficiency virus. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Sex Transm Dis. 1998 Sep;25(8):443-7. doi: 10.1097/00007435-199809000-00012.
• Background Vazquez JA, Sobel JD, Peng G, Steele-Moore L, Schuman P, Holloway W, Neaton JD. Evolution of vaginal Candida species recovered from human immunodeficiency virus-infected women receiving fluconazole prophylaxis: the emergence of Candida glabrata? Terry Beirn Community Programs for Clinical Research in AIDS (CPCRA). Clin Infect Dis. 1999 May;28(5):1025-31. doi: 10.1086/514746.
• Background Vazquez JA, Peng G, Sobel JD, Steele-Moore L, Schuman P, Holloway W, Neaton JD. Evolution of antifungal susceptibility among Candida species isolates recovered from human immunodeficiency virus-infected women receiving fluconazole prophylaxis. Clin Infect Dis. 2001 Oct 1;33(7):1069-75. doi: 10.1086/322641. Epub 2001 Sep 5.

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