SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
- Conditions
- Meningitis, CryptococcalHIV Infections
- Registration Number
- NCT00000677
- Brief Summary
To assess the safety and effectiveness of SCH 39304 as primary treatment of acute cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance therapy following successful treatment of acute disease are also evaluated.
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
- Detailed Description
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
HIV-infected patients with a diagnosis of acute cryptococcal meningitis, previously untreated or relapsed following a successfully treated acute episode, are enrolled in the study. SCH 39304 is administered orally once daily for 3 days followed by a lower dose once daily for 12 weeks. Patients who respond to primary therapy are randomized to receive SCH 39304 maintenance therapy at a higher dose once weekly or at the lower dose once daily for up to 12 months under this protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Ohio State Univ Med Ctr
🇺🇸Columbus, Ohio, United States
Dr Robert Larsen
🇺🇸Los Angeles, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Univ Hosp
🇺🇸Boston, Massachusetts, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
Birmingham Veterans Administration Med Ctr
🇺🇸Birmingham, Alabama, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Houston Veterans Administration Med Ctr
🇺🇸Houston, Texas, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Emory Univ School of Medicine
🇺🇸Atlanta, Georgia, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St Louis, Missouri, United States
Erie County Med Ctr
🇺🇸Buffalo, New York, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Univ TX Health Science Ctr
🇺🇸Houston, Texas, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Audie L Murphy Veterans Administration Hosp
🇺🇸San Antonio, Texas, United States