Status:
COMPLETED
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Pfizer
Conditions:
Candidiasis
Candidiasis, Esophageal
Eligibility:
FEMALE
13+ years
Phase:
NA
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....
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 i...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 1995
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00000744
End Date
December 1 1995
Last Update
November 3 2021
Active Locations (16)
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1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
3
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
4
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422