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Clinical Trials

MainTitle

A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Pfizer

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000744

First received: November 2, 1999
Last updated: September 28, 2013
Last Verified: September 2013
History of Changes
Purpose

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

Study Type: Interventional
Study Design: Masking: Double
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

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

Enrollment: 400
Study Completion Date: December 1995

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes 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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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, 80204
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
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
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
Clinical Directors Network of Region II
New York, New York, United States, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Pfizer

Investigators

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

More Information


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: September 28, 2013  

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
Candidiasis
Fluconazole

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.