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

NCT00000744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-11-03

No results posted yet for this study

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.

Conditions

  • Candidiasis
  • Candidiasis, Esophageal
  • HIV Infections

Interventions

DRUG

Fluconazole

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • P Schuman

  • L Capps

Study Design

Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Completion
1995-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000744 on ClinicalTrials.gov