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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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.
Condition | Intervention |
---|---|
Candidiasis Candidiasis, Esophageal HIV Infections |
Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women |
Estimated Enrollment: | 400 |
Study Completion Date: | December 1995 |
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.
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Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
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United States, California | |
Community Consortium of San Francisco | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, Delaware | |
Wilmington Hosp / Med Ctr of Delaware | |
Wilmington, Delaware, United States, 19899 | |
United States, District of Columbia | |
Veterans Administration Med Ctr / Regional AIDS Program | |
Washington, District of Columbia, United States, 20422 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
Comprehensive AIDS Alliance of Detroit | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
United States, New York | |
Bronx Lebanon Hosp Ctr | |
Bronx, New York, United States, 10456 | |
Addiction Research and Treatment Corp | |
Brooklyn, New York, United States, 11201 | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
Clinical Directors Network of Region II | |
New York, New York, United States, 10011 | |
United States, Oregon | |
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
Portland, Oregon, United States, 972109951 | |
United States, Virginia | |
Richmond AIDS Consortium | |
Richmond, Virginia, United States, 23298 |
Study Chair: | P Schuman | |
Study Chair: | L Capps |
![](https://webarchive.library.unt.edu/web/20130309094734im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000744 History of Changes |
Other Study ID Numbers: | CPCRA 010, 11562 |
Study First Received: | November 2, 1999 |
Last Updated: | March 30, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Fluconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Esophageal Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Mycoses Gastrointestinal Diseases Digestive System Diseases Fluconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 07, 2013