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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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Pfizer
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000744
  Purpose

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

MedlinePlus related topics:   AIDS    Esophagus Disorders    Yeast Infections   

Drug Information available for:   Fluconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Efficacy Study
Official Title:   A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   400

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000744

Locations
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
Harlem AIDS Treatment Group / Harlem Hosp Ctr    
      New York, New York, United States, 10037
Bronx Lebanon Hosp Ctr    
      Bronx, New York, United States, 10456
Clinical Directors Network of Region II    
      New York, New York, United States, 10011
Addiction Research and Treatment Corp    
      Brooklyn, New York, United States, 11201
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

Sponsors and Collaborators

Investigators
Study Chair:     P Schuman    
Study Chair:     L Capps    
  More Information


Click here for more information about Fluconazole  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   CPCRA 010
First Received:   November 2, 1999
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00000744
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  

Study placed in the following topic categories:
Fluconazole
Sexually Transmitted Diseases, Viral
Candidiasis
Esophageal disorder
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
Sexually Transmitted Diseases
Neoplasm Metastasis
Esophageal Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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