A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
- Conditions
- Candidiasis, OralHIV Infections
- Registration Number
- NCT00000951
- 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.
- Detailed Description
This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of oropharyngeal candidiasis and fluconazole-refractory infections.
Prior to randomization to a long-term management strategy using fluconazole, patients are stratified into one of three groups according to their baseline CD4+ count (cells/mm3): 0-49, 50-100, and 101-150. Patients without oropharyngeal candidiasis (no thrush present) at enrollment and those patients who respond (no thrush present) to the initial acute therapy for an active infection are randomized 1:1 to one of two management strategies for fluconazole: Arm A (episodic therapy) or Arm B (chronic suppressive therapy with continuous fluconazole). Patients are then followed for a duration of 24 months after enrollment of the last subject. Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond (no thrush present) are then randomized to a long-term management strategy. Those who do not respond (refractory disease) to the acute treatment are permanently discontinued from the study. Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 948
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
State of MD Div of Corrections / Johns Hopkins Univ Hosp
🇺🇸Baltimore, Maryland, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, 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 Washington
🇺🇸Seattle, Washington, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Kentucky Lexington
🇺🇸Cincinnati, Ohio, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Institute for Clinical Research
🇺🇸Washington, District of Columbia, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Saint Clare's Hosp and Health Ctr
🇺🇸New York, New York, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
🇺🇸Atlanta, Georgia, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
St Paul Ramsey Med Ctr
🇺🇸Saint Paul, Minnesota, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸Saint Louis, Missouri, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Philadelphia Veterans Administration Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
🇺🇸Rochester, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Hennepin County Med Clinic
🇺🇸Minneapolis, Minnesota, United States
Univ of Iowa Hosp and Clinic
🇺🇸Iowa City, Iowa, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States