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:
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

November 2, 1999
September 28, 2013
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Complete list of historical versions of study NCT00000744 on ClinicalTrials.gov Archive Site
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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
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Candidiasis
  • Candidiasis, Esophageal
  • HIV Infections
Drug: Fluconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 1995
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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.
Female
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000744
CPCRA 010, 11562
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Pfizer
Study Chair: P Schuman
Study Chair: L Capps
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP