Comparison of 2 Doses of Liposomal Amphotericin B and Conventional Amphotericin B Deoxycholate for Treatment of AIDS-Associated Acute Cryptococcal Meningitis: A Randomized, Double-Blind Clinical Trial of Efficacy and Safety

Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretrov...

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Bibliographic Details
Published in:Clinical infectious diseases 2010-07, Vol.51 (2), p.225-232
Main Authors: Hamill, Richard J., Sobel, Jack D., El-Sadr, Wafaa, Johnson, Philip C., Graybill, John R., Javaly, Kedarnath, Barker, David E., Baker, Carol J.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
AIDS
AIDS-Related Opportunistic Infections - drug therapy
Amphotericin B - administration & dosage
Amphotericin B - adverse effects
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antifungal agents
Antifungal Agents - administration & dosage
Antifungal Agents - adverse effects
Biological and medical sciences
Canada
Cerebrospinal fluid
Child
Comparative analysis
Creatinine - blood
Cryptococcal meningitis
Deoxycholic Acid - administration & dosage
Deoxycholic Acid - adverse effects
Dosage
Double-Blind Method
Drug Combinations
Effects
Experimentation
Female
Fungal infections
Highly active antiretroviral therapy
HIV/AIDS
Human mycoses
Human viral diseases
Humans
Infectious diseases
Kidney Diseases - chemically induced
Lipids
Male
Medical sciences
Medical treatment
Meningitis
Meningitis, Cryptococcal - drug therapy
Meningitis, Cryptococcal - mortality
Middle Aged
Miscellaneous mycoses
Mortality
Mycoses
Pharmacology. Drug treatments
State hospitals
Studies
Treatment Outcome
United States
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Young Adult
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Summary:Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretroviral therapy, was designed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome (AIDS) and acute cryptococcal meningitis. Methods. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day (n=87), liposomal amphotericin B at 3 mg/kg/day (n=86), or liposomal amphotericin B at 6 mg/kg/day (n=94). Results. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B, compared with conventional amphotericin B (P
ISSN:1058-4838
1537-6591
DOI:10.1086/653606