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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Four hundred HIV-infected women are randomized to receive fluconazole or placebo weekly for up to 2 years. Patients undergo follow-up every 3 months or more often if signs and symptoms of mucosal candidiasis occur.

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

Conditions
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Candidiasis, Candidiasis, Esophageal, HIV Infections

Intervention / Treatment
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* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Evidence of HIV infection. CD4+ count <= 300 cells/mm3 or <= 20 percent of total lymphocyte count. Reasonably good health with a life expectancy of at least 6 months. Pelvic exam including Pap smear or colposcopy performed within the past 90 days. Prior Medication: Allowed: Topical or systemic treatment or prophylaxis with an antifungal agent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Current diagnosis of Candida esophagitis. Known intolerance to azoles. Concurrent Medication: Excluded: Systemic treatment or prophylaxis with an antifungal agent. Patients with the following prior conditions are excluded: Past history of Candida esophagitis.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluconazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis