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) logo

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.

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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