High dose amphotericin B with flucytosine, and amphotericin B plus high dose fluconazole for treatment of cryptococcal meningitis in human immunodeficiency (HIV)-infected patients
Completed
- Conditions
- Cryptococcal meningitisInfections and Infestations
- Registration Number
- ISRCTN68133435
- Lead Sponsor
- St. George's Medical School (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. 18 years old or more, either sex
2. Human immunodeficiency virus (HIV) seropositive
3. First episode of cryptococcal meningitis on basis of positive cerebrospinal fluid (CSF) India ink or CSF cryptococcal antigen
Exclusion Criteria
1. Liver function test - alanine aminotransferase (ALT) formerly known as serum glutamate pyruvate transaminase (SGPT) greater than five times upper limit of normal
2. Absolute neutrophil count less than 500 x 10^6/l
3. Platelets less than 50,000 x 10^6/l^3
4. Creatinine greater than 2.5 mg/dl^4
5. Pregnant or lactating women
6. Previous serious reaction to any of the study drugs
7. Currently taking systemic antifungal therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early fungicidal activity (EFA) of alternative regimens based on serial quantitative CSF cultures over the first two weeks of therapy.
- Secondary Outcome Measures
Name Time Method 1. Clinical and laboratory side effects<br>2. Mortality and morbidity at ten weeks