High dose amphotericin B with flucytosine, and amphotericin B plus high dose fluconazole for treatment of cryptococcal meningitis in human immunodeficiency (HIV)-infected patients

Early fungicidal activity of high dose amphotericin B combined with flucytosine, liposomal amphotericin B with flucytosine, amphotericin B and high dose fluconazole compared with standard amphotericin B and flucytosine for the initial treatment of human immunodeficiency virus associated cryptococcal meningitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68133435

Enrollment

150

Registered

2006-02-08

Start date

2005-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptococcal meningitis Infections and Infestations Cryptococcal meningitis

Interventions

Step 1: high dose amphotericin B (1 mg/kg/day) plus flucytosine versus standard dose amphotericin B (0.7 mg/kg/day) plus flucytosine, for initial therapy. Substudy step 1: high dose liposomal amphoter

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Early fungicidal activity (EFA) of alternative regimens based on serial quantitative CSF cultures over the first two weeks of therapy.	—

Secondary

Measure	Time frame
1. Clinical and laboratory side effects 2. Mortality and morbidity at ten weeks	—

Countries

South Africa, Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026