Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study

• Published in: The American journal of tropical medicine and hygiene Vol. 66; no. 2; pp. 143 - 146
• Main Authors: Sundar, S, Jha, TK, Thakur, CP, Mishra, M, Singh, VR, Buffels, R
• Format: Journal Article
• Language: English
• Published: Lawrence, KS ASTMH 01.02.2002; Allen Press
• Subjects: Adolescent; Adult; Amphotericin B - administration & dosage; Amphotericin B - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antimony - therapeutic use; Antiparasitic agents; Antiprotozoal Agents - administration & dosage; Antiprotozoal Agents - therapeutic use; Biological and medical sciences; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Human protozoal diseases; Humans; India; Infectious diseases; Leishmaniasis, Visceral - drug therapy; Leshmaniasis; Male; Medical sciences; Parasitic diseases; Pharmacology. Drug treatments; Protozoal diseases; Treatment Outcome; Tropical medicine; Asia; India; Human; Protozoal disease; Low dose; Treatment efficiency; Multicenter study; Liposome; Kala azar; Leishmaniasis; Parasitosis; Infection; Antibiotic; Antifungal agent; Chemotherapy; Treatment; Amphotericin B; Polyenic compound; Parasiticid; Dosage form
• ISSN: 0002-9637; 1476-1645
• DOI: 10.4269/ajtmh.2002.66.143

In this randomized, double-blind, dose-ranging, multicenter trial, 84 patients with visceral leishmaniasis refractory to antimony therapy were administered liposomal amphotericin B (AmBisome) at cumulative doses of 3.75, 7.5, and 15.0 mg/kg for 5 consecutive days. Posttreatment apparent cure and definite cure were assessed at 2 weeks and 6 months after the end of therapy, respectively. Mild to moderate infusion-related fever and rigors were seen in 29 and 44% of patients, respectively. One patient each in the 3.75- and 7.5-mg groups had detectable parasites on splenic smear at posttreatment evaluation. At 6 months' follow-up, however, 2, 1, and 1 patients relapsed in the 3.75-, 7.5-, and 15.0-mg groups, resulting in definite cure rates of 89, 93, and 97%, respectively. There was no significant difference in the cure rates of the 3 groups. Low-dose liposomal amphotericin B given for 5 days can cure most patients with Indian kala-azar.