A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis; Candidiasis, Esophageal; HIV Infections
Intervention: Fluconazole (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
P Schuman, Study Chair
L Capps, Study Chair
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.
Clinical Details
Official title: A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Study design: Treatment, Double-Blind, Efficacy Study
Detailed 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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Community Consortium of San Francisco, San Francisco, California 94110, United States
Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States
Wilmington Hosp / Med Ctr of Delaware, Wilmington, Delaware 19899, United States
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States
North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States
Clinical Directors Network of Region II, New York, New York 10011, United States
Addiction Research and Treatment Corp, Brooklyn, New York 11201, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 972109951, United States
Richmond AIDS Consortium, Richmond, Virginia 23298, United States
Additional Information
Click here for more information about Fluconazole
Related publications: 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.
Last updated: June 23, 2005
|
