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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

Primary Purpose

Candidiasis, Candidiasis, Esophageal, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluconazole
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Community Consortium of San Francisco
  • Denver CPCRA / Denver Public Hlth
  • Wilmington Hosp / Med Ctr of Delaware
  • Veterans Administration Med Ctr / Regional AIDS Program
  • AIDS Research Consortium of Atlanta
  • AIDS Research Alliance - Chicago
  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
  • Comprehensive AIDS Alliance of Detroit
  • Henry Ford Hosp
  • North Jersey Community Research Initiative
  • Bronx Lebanon Hosp Ctr
  • Addiction Research and Treatment Corp
  • Clinical Directors Network of Region II
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Richmond AIDS Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00000744
Brief Title
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1995 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Pfizer

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Candidiasis, Esophageal, HIV Infections
Keywords
Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P Schuman
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
L Capps
Official's Role
Study Chair
Facility Information:
Facility Name
Community Consortium of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver CPCRA / Denver Public Hlth
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Wilmington Hosp / Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Veterans Administration Med Ctr / Regional AIDS Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Comprehensive AIDS Alliance of Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Clinical Directors Network of Region II
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9139554
Citation
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.
Results Reference
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PubMed Identifier
9773440
Citation
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.
Results Reference
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PubMed Identifier
10452629
Citation
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.
Results Reference
background
PubMed Identifier
11528582
Citation
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.
Results Reference
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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

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