HIV Infections Clinical Trial
Official title:
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
NCT number | NCT00002075 |
Other study ID # | 012G |
Secondary ID | 056-159A |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria Concurrent Medication: Allowed: - Immunosuppressant therapy. - Antiviral such as zidovudine. - Radiation therapy for mucocutaneous Kaposi's sarcoma. - Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine. Concurrent Treatment: Allowed: - Radiation therapy for mucocutaneous Kaposi's sarcoma. Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. - No prior systemic antifungal therapy for cryptococcosis. - Relapse after prior therapy. - Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study. Prior Medication: Allowed: - Immunosuppressant therapy. - Antivirals such as zidovudine (AZT). - Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. - History of allergy to or intolerance of imidazoles, azoles, or amphotericin B. - Moderate or severe liver disease. - Comatose. - Unlikely to survive more than 2 weeks. - Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. Concurrent Medication: Excluded: - Coumadin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications. - Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. - Excluded within 4 weeks of study entry: - Received more than 1 mg/kg/wk amphotericin B. Concurrent Treatment: Excluded: - Lymphocyte replacement. Patients with the following are excluded: - Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. - History of allergy to or intolerance of imidazoles, azoles, or amphotericin B. - Moderate or severe liver disease. - Comatose. - Unlikely to survive more than 2 weeks. Prior Medication: Excluded: - Coumadin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications. - Excluded within 4 weeks of study entry: - More than 1 mg/kg/wk amphotericin B. Prior Treatment: Excluded: - Lymphocyte replacement. |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dr Robert Larsen | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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