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

NCT00000744

Last updated date
Study Location
Community Consortium of San Francisco
San Francisco, California, 94110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Esophageal Candidiasis, HIV Infections
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Candidiasis, Esophageal Candidiasis, HIV InfectionsA Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
NCT00000744
  1. San Francisco, California
  2. Denver, Colorado
  3. Wilmington, Delaware
  4. Washington, District of Columbia
  5. Atlanta, Georgia
  6. Chicago, Illinois
  7. New Orleans, Louisiana
  8. Detroit, Michigan
  9. Detroit, Michigan
  10. Newark, New Jersey
  11. Bronx, New York
  12. Brooklyn, New York
  13. New York, New York
  14. New York, New York
  15. Portland, Oregon
  16. Richmond, Virginia
Female
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Official Title  ICMJE A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis
  • Candidiasis, Esophageal
  • HIV Infections
Intervention  ICMJE Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1995
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000744
Other Study ID Numbers  ICMJE CPCRA 010
11562 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:P Schuman
Study Chair:L Capps
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date September 2013

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