A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Fluconazole
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
Community Consortium of San Francisco
San Francisco, United StatesOpen Community Consortium of San Francisco in Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesWilmington Hosp / Med Ctr of Delaware
Wilmington, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United States