A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 400
- Locations
- 16
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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:
- •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:
- •Systemic treatment or prophylaxis with an antifungal agent.
- •Patients with the following prior conditions are excluded:
- •Past history of Candida esophagitis.