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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• • 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.

Trial Officials