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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Candidiasis, Esophageal; Candidiasis; HIV Infections

Treatments: Drug: Fluconazole

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00000744

CPCRA 010

11562 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.