SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy

Completed · Phase 1

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000677

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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