A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis
2 other identifiers
interventional
948
2 countries
54
Brief Summary
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush. Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2002
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4+ cell count less than 150 cells/mm3.
- Had at least one episode of thrush in the 24 months before study entry.
- Have a life expectancy of at least 12 months.
- Weigh at least 88 pounds.
- Are 13 years of age or older (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use effective methods of birth control during the study.
You may not qualify if:
- You will not be eligible for this study if you:
- Have an allergy to azoles.
- Have had 3 episodes or more of thrush within 12 weeks of study entry.
- Have a history of esophageal candidiasis.
- Have a history of fluconazole-resistant infection.
- Have an active opportunistic infection requiring treatment within 14 days before study entry.
- Have a fungal infection requiring certain medications.
- Have a severe liver disease (e.g., cirrhosis).
- Are unable to tolerate oral medications.
- Take certain medications.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Institute for Clinical Research
Washington D.C., District of Columbia, 20422, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225, United States
Queens Med Ctr
Honolulu, Hawaii, 96816, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Saint Clare's Hosp and Health Ctr
New York, New York, 10019, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Univ of Washington
Seattle, Washington, 98104, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (1)
Swindells S, Evans S, Zackin R, Goldman M, Haubrich R, Filler SG, Balfour HH Jr; AIDS Clinical Trial Group 722 Study Team. Predictive value of HIV-1 viral load on risk for opportunistic infection. J Acquir Immune Defic Syndr. 2002 Jun 1;30(2):154-8. doi: 10.1097/00042560-200206010-00003.
PMID: 12045677BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mitchell Goldman
- STUDY CHAIR
Scott G. Filler
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 2002
Last Updated
October 29, 2021
Record last verified: 2021-10