Cryptococcal meningitis/ HIV Infections and Infestations Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Conditions
Interventions
Step 1:
1. Fluconazole 1,200 mg/d for two weeks
2. Fluconazole 1,200 mg/d plus flucytosine 100 mg/kg/d for two weeks
After two weeks all patients receive fluconazole 800 mg/d.
Step 2:
1. Amphoteri
Sponsors
St George's University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients greater than 18 years, either sex 2. A first episode of cryptococcal meningitis
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early fungicidal activity (rate of clearance of infection) of alternative regimens over the first two weeks of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical and laboratory side effects 2. Mortality at 2 and 10 weeks | — |
Countries
Malawi
Outcome results
None listed