A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
- Conditions
- CandidiasisCandidiasis, EsophagealHIV Infections
- Registration Number
- NCT00000744
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Community Consortium of San Francisco
🇺🇸San Francisco, California, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Veterans Administration Med Ctr / Regional AIDS Program
🇺🇸Washington, District of Columbia, United States
Wilmington Hosp / Med Ctr of Delaware
🇺🇸Wilmington, Delaware, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Addiction Research and Treatment Corp
🇺🇸Brooklyn, New York, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Clinical Directors Network of Region II
🇺🇸New York, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Comprehensive AIDS Alliance of Detroit
🇺🇸Detroit, Michigan, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States