Clareo Health | A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Institute of Allergy and Infectious Diseases (NIAID)
With
Pfizer
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.
Age
13–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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:
