Cryptococcal meningitis Infections and Infestations Meningitis
Conditions
Interventions
Group 1: Amphotericin B 1 mg/kg/d plus flucytosine 25 mg/kg four times a day (qds) for two weeks.
Group 2: Amphotericin B 1 mg/kg/d plus flucytosine 25 mg/kg qds for two weeks plus interferon (IFN)-g
Sponsors
St George's University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients greater than 18 years (either sex) with a first episode of cryptococcal meningitis on basis of CSF India ink or CSF cryptococcal antigen.
Exclusion criteria
Exclusion criteria: 1. Alanine Aminotransferase (ALT) greater than five times upper limit of normal 2. Polymorphonuclear leukocytes (PMNs) less than 500 x 10^6/L 3. Platelets (Plts) less than 50,000 x 10^6/L 4. Pregnancy or lactation 5. Previous serious reaction to study drugs 6. Concomitant medication that is contraindicated with any study drugs 7. Already on Anti-Retroviral Therapy (ART)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early Fungicidal Activity (EFA, the rate of sterilisation of CSF), for each treatment arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportions of patients in each arm suffering clinical and laboratory-defined side effects 2. Mortality at 2 and 10 weeks by treatment group | — |
Countries
South Africa
Outcome results
None listed