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

• Status: Completed
• Trial end date: 1995-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Pfizer
• Treatments: Fluconazole

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.