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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000744

Enrollment

400

Registered

2001-08-31

Start date

Unknown

Completion date

1995-12-31

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis, Candidiasis, Esophageal, HIV Infections

Keywords

Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis

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.

Interventions

DRUGFluconazole

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

13 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026