A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

Completed · Phase 4

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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.

Key facts

Study ID: NCT00000951
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 948
Expected to finish: 2002-05-01
Last updated by the study team: 2021-10-29

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

UCLA CARE Ctr — Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr — San Diego, California, United States
San Francisco Gen Hosp — San Francisco, California, United States
Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
Howard Univ — Washington D.C., District of Columbia, United States
Institute for Clinical Research — Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine — Miami, Florida, United States
Emory Univ — Atlanta, Georgia, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr — Atlanta, Georgia, United States
Queens Med Ctr — Honolulu, Hawaii, United States
Univ of Hawaii — Honolulu, Hawaii, United States
Northwestern Univ Med School — Chicago, Illinois, United States
Cook County Hosp — Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
Indiana Univ Hosp — Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
Univ of Iowa Hosp and Clinic — Iowa City, Iowa, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp — Baltimore, Maryland, United States
Johns Hopkins Hosp — Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
Boston Med Ctr — Boston, Massachusetts, United States
Hennepin County Med Clinic — Minneapolis, Minnesota, United States
Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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