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A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women Clinical research trials and A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women clinical trial. Participants frequently get the best healthcare available for their A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
For Condition: Candidiasis,Candidiasis, esophageal,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Pfizer
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
PSchuman, Study Chair,
Clinical Directors Network of Region II
New York City, New York, 10011
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Community Consortium of San Francisco
San Francisco, California, 94110
United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
United States
Additional Information:
Study ID Numbers: CPCRA 010;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000744
Other Candidiasis, Esophageal Studies:
1. A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
2. Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
3. A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
4. Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
5. A Study of the Side Effects of L-743,872 in Men with Candidal Esophagitis
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Other Candidiasis, esophageal Clinical Trials
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A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
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