High dose fluconazole with or without flucytosine in the treatment of human immunodeficiency virus (HIV)-associated cryptococcal meningitiscryptococcal meningitis
Completed
- Conditions
- Cryptococcal meningitis/ HIVInfections and InfestationsHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
- Registration Number
- ISRCTN02725351
- Lead Sponsor
- St George's University of London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Patients greater than 18 years, either sex
2. A first episode of cryptococcal meningitis
Exclusion Criteria
1. Alanine aminotransferase (ALT) greater than five times the upper limit of normal
2. Pregnancy or lactation
3. Previous serious reaction to study drugs
4. Taking systemic anti-fungals
5. Polymorphonuclear leukocytes (PMNs) less than 500 x 10^6/L
6. Platelets less than 50,000 x 10^6/L
7. Concomitant medication that is contraindicated with any study drugs
8. Already on antiretroviral therapy (ART)
STEP 2 additional criteria:
9. Initial creatinine greater than 2.5 mg/dl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early fungicidal activity (rate of clearance of infection) of alternative regimens over the first two weeks of therapy.
- Secondary Outcome Measures
Name Time Method 1. Clinical and laboratory side effects <br>2. Mortality at 2 and 10 weeks