Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS
- Conditions
- Meningitis, CryptococcalHIV Infections
- Registration Number
- NCT00001017
- Lead Sponsor
- Pfizer
- Brief Summary
To compare the safety and effectiveness of a new drug, fluconazole, with that of the usual therapy, amphotericin B, in the prevention of a relapse of cryptococcal meningitis (CM) in patients with AIDS who have been successfully treated for acute CM in the last 6 months.
Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug.
- Detailed Description
Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an antifungal agent that can be given orally and has been shown to be effective against cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the side effects experienced by over 2000 patients or volunteers given fluconazole have seldom been severe enough to require withdrawal of the drug.
Patients accepted in the trial are randomly assigned to fluconazole or amphotericin B. Fluconazole is given orally once a day and amphotericin B is given intravenously once a week. Dosages depend on body weight. Medications may be given with amphotericin B to prevent or reduce discomfort from associated side effects. Patients are treated for 12 months and may continue to receive antiviral therapy, radiation therapy for mucocutaneous Kaposi's sarcoma, or preventive therapy for Pneumocystis carinii pneumonia (PCP) during the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
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 (28)
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
SUNY - Stony Brook
🇺🇸Stony Brook, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Louisiana State Univ School of Medicine
🇺🇸New Orleans, Louisiana, 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
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
North Central Bronx Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Beth Israel Med Ctr / Peter Krueger Clinic
🇺🇸New York, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States