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

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Candidiasis Candidiasis, Esophageal HIV Infections	Drug: Fluconazole	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	400 participants
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Actual Study Completion Date :	December 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Yeast Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000744

Locations

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United States, California
Community Consortium of San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
United States, Delaware
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program
Washington, District of Columbia, United States, 20422
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
United States, Michigan
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Clinical Directors Network of Region II
New York, New York, United States, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Pfizer

Investigators

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Study Chair:	P Schuman
Study Chair:	L Capps

More Information

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. doi: 10.7326/0003-4819-126-9-199705010-00003.

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. doi: 10.1097/00007435-199809000-00012.

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. doi: 10.1086/514746.

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. doi: 10.1086/322641. Epub 2001 Sep 5.

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Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000744
Other Study ID Numbers:	CPCRA 010 11562 ( Registry Identifier: DAIDS ES Registry Number )
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	November 3, 2021
Last Verified:	October 2021

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):


Fluconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis

Additional relevant MeSH terms:

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Candidiasis Infections Mycoses Bacterial Infections and Mycoses Fluconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors