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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00000677 |
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Date of registration:
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02/11/1999 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
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Scientific title:
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SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy |
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Date of first enrolment:
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July 2000 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00000677 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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WG Powderly |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Meningitis, Cryptococcal
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HIV Infections
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Intervention(s)
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Drug: SCH 39304
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Secondary ID(s)
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ACTG 125
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C89-258
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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