Completed
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03
400
Participants Needed
16
Research Sites
N/A
Total Duration
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
P
Pfizer
Collaborating Sponsor
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.
CONDITIONS
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
You may qualify if you...
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Total: 16 locations
1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
Status Unknown
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
Status Unknown
3
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
Status Unknown
4
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422
Status Unknown
5
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Status Unknown
6
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Status Unknown
7
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Status Unknown
8
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Status Unknown
9
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Status Unknown
10
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
Status Unknown
11
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Status Unknown
12
Clinical Directors Network of Region II
New York, New York, United States, 10011
Status Unknown
13
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
14
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10456
Status Unknown
15
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
Status Unknown
16
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Status Unknown
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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https://pubmed.ncbi.nlm.nih.gov/9139554L Capps, G Peng, M Doyle...
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