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Home > "S" Clinical Trials Conditions > SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy  SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Schering-Plough
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. 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 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. - 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.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
WGPowderly, Study Chair,
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ TX Health Science Ctr
Houston, Texas, 77030
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Erie County Med Ctr
Buffalo, New York, 14215
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Birmingham Veterans Administration Med Ctr
Birmingham, Alabama, 35233
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Dr Robert Larsen
Los Angeles, California, 90033
United States
Ohio State Univ Med Ctr
Columbus, Ohio, 43210
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Univ Hosp
Boston, Massachusetts, 02118
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ACTG 125; C89-258
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000677
Other Hiv Infections Studies:
1. Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
2. Dexamethasone in Cryptococcal Meningitis
3. Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients with AIDS
4. The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
5. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
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