A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Completed · Not applicable
Conditions studied: Candidiasis, Candidiasis, Esophageal, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000744
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 400
- Expected to finish
- 1995-12-01
- Last updated by the study team
- 2021-11-03
Who can join
Age: 13 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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:
- Past history of Candida esophagitis.
Where it is running
- Community Consortium of San Francisco — San Francisco, California, United States
- Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
- Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
- Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
- AIDS Research Alliance - Chicago — Chicago, Illinois, United States
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
- Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
- Henry Ford Hosp — Detroit, Michigan, United States
- North Jersey Community Research Initiative — Newark, New Jersey, United States
- Addiction Research and Treatment Corp — Brooklyn, New York, United States
- Clinical Directors Network of Region II — New York, New York, United States
- Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
- Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
- Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
- Richmond AIDS Consortium — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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