Status:
COMPLETED
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Schering-Plough
Conditions:
Meningitis, Cryptococcal
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
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...
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. ...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00000677
Last Update
June 24 2005
Active Locations (28)
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1
Birmingham Veterans Administration Med Ctr
Birmingham, Alabama, United States, 35233
2
Dr Robert Larsen
Los Angeles, California, United States, 90033
3
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
4
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859