A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
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...
Brief Summary
Official Title: “A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Fluconazole
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute of Allergy and Infectious Diseases (NIAID) NIH
Overall Clinical Trial Officials and Contacts
P Schuman Study Chair
Related Publications
References
Schuman P, Capps L, Peng G, Vazquez J, el-Sadr W, Goldman AI, Alston B, Besch CL, Vaughn A, Thompson MA, Cobb MN, Kerkering T, Sobel JD. Weekly fluconazole for the prevention of mucosal candidiasis in women with HIV infection. A randomized, double-blind, placebo-controlled trial. Terry Beirn Community Programs for Clinical Research on AIDS. Ann Intern Med. 1997 May 1;126(9):689-96.
Capps L, Peng G, Doyle M, El-Sadr W, Neaton JD. Sexually transmitted infections in women infected with the human immunodeficiency virus. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Sex Transm Dis. 1998 Sep;25(8):443-7.
Vazquez JA, Sobel JD, Peng G, Steele-Moore L, Schuman P, Holloway W, Neaton JD. Evolution of vaginal Candida species recovered from human immunodeficiency virus-infected women receiving fluconazole prophylaxis: the emergence of Candida glabrata? Terry Beirn Community Programs for Clinical Research in AIDS (CPCRA). Clin Infect Dis. 1999 May;28(5):1025-31.
Vazquez JA, Peng G, Sobel JD, Steele-Moore L, Schuman P, Holloway W, Neaton JD. Evolution of antifungal susceptibility among Candida species isolates recovered from human immunodeficiency virus-infected women receiving fluconazole prophylaxis. Clin Infect Dis. 2001 Oct 1;33(7):1069-75.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000744
Study ID Number: CPCRA 010
ClinicalTrials.gov Identifier: NCT00000744
Health Authority: United States: Federal Government
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00000744
