SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
2 other identifiers
interventional
50
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
28 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
CompletedJune 24, 2005
December 1, 1994
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Currently approved antiviral therapy.
- Maintenance therapy for cytomegalovirus retinitis or toxoplasmosis.
- Rifampin.
- Isoniazid.
- Dilantin or barbiturates if investigator agrees to rigorously monitor anticonvulsant drug levels.
- Coumarin-type anticoagulants if investigator agrees to rigorously monitor prothrombin time.
- Prophylactic treatment for Pneumocystis carinii pneumonia (PCP).
- Concurrent Treatment:
- Allowed:
- Local radiotherapy for mucocutaneous Kaposi's sarcoma.
- Prior Medication:
- Allowed:
- Amphotericin B, up to 1 mg/kg, during the previous 7 days.
- +3 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- History of hypersensitivity to imidazole or azole compounds.
- Central nervous system disease.
- Acute opportunistic infection.
- Underlying conditions that in the opinion of the investigator could preclude assessment of response.
- Concurrent Medication:
- Excluded:
- Systemic antifungal drugs other than study drug.
- Any investigational drug other than treatment IND drugs.
- Oral hypoglycemic agents.
- Oral contraceptives.
- Cytotoxic chemotherapy.
- Patients with the following are excluded:
- Unable to take oral medications.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Birmingham Veterans Administration Med Ctr
Birmingham, Alabama, 35233, United States
Dr Robert Larsen
Los Angeles, California, 90033, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Univ Hosp
Boston, Massachusetts, 02118, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Erie County Med Ctr
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ Med Ctr
Columbus, Ohio, 43210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Univ TX Health Science Ctr
Houston, Texas, 77030, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, United States
Richmond AIDS Consortium
Richmond, Virginia, 23219, United States
Related Publications (1)
Lee BL, Padula AM, Tauber MG, Chambers HF, Sande MA. Oral SCH 39304 as primary, salvage, and maintenance therapy for cryptococcal meningitis in AIDS. J Acquir Immune Defic Syndr (1988). 1992;5(6):600-4.
PMID: 1588494BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
WG Powderly
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1994-12