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

Not Applicable

Completed

• Conditions: Candidiasis; Candidiasis, Esophageal; HIV Infections

• Registration Number: NCT00000744
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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 Timeline

• Study Completion: 1995-12
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (16)

Community Consortium of San Francisco; 🇺🇸 San Francisco, California, United States

Denver CPCRA / Denver Public Hlth; 🇺🇸 Denver, Colorado, United States

Wilmington Hosp / Med Ctr of Delaware; 🇺🇸 Wilmington, Delaware, United States

Veterans Administration Med Ctr / Regional AIDS Program; 🇺🇸 Washington, District of Columbia, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

AIDS Research Alliance - Chicago; 🇺🇸 Chicago, Illinois, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med; 🇺🇸 New Orleans, Louisiana, United States

Comprehensive AIDS Alliance of Detroit; 🇺🇸 Detroit, Michigan, United States

Henry Ford Hosp; 🇺🇸 Detroit, Michigan, United States

North Jersey Community Research Initiative; 🇺🇸 Newark, New Jersey, United States

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