SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
NCT ID: NCT00000677
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
50 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCH 39304
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Patients must be HIV positive by 2 methodologies and have either primary cryptococcal meningitis with no prior anti-cryptococcal therapy or relapsed disease after prior therapy.
* Prior therapy for cryptococcal meningitis is limited to approved drugs.
* Written informed consent either from patient or patient's parent or legal guardian is required.
Exclusion Criteria
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.
* Concurrent central nervous system disease which in opinion of investigator would interfere with assessment of response.
* Concurrent acute opportunistic infection requiring therapy (patients who develop an acute opportunistic infection after initiation of study medication may remain on study medication).
Prior Medication:
Excluded within 7 days of study entry:
* Amphotericin B, \> 1 mg/kg.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Schering-Plough
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
WG Powderly
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham Veterans Administration Med Ctr
Birmingham, Alabama, United States
Dr Robert Larsen
Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Emory Univ School of Medicine
Atlanta, Georgia, United States
Med College of Georgia
Augusta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Univ Hosp
Boston, Massachusetts, 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
Beth Israel Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States
Ohio State Univ Med Ctr
Columbus, Ohio, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Univ TX Health Science Ctr
Houston, Texas, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C89-258
Identifier Type: -
Identifier Source: secondary_id
ACTG 125
Identifier Type: -
Identifier Source: org_study_id