Comparison of three treatment regimens with liposomal amphotericin B (AmBisome) for visceral leishmaniasis in India: a randomized dose-finding study.

Abstract

The efficacy and safety of 3 regimens of liposomal amphotericin B (AmBisome) in the treatment of Indian visceral leishmaniasis were compared in a prospective open randomized trial. Thirty parasitologically confirmed patients were randomly divided into 3 equal treatment groups; group 1 received AmBisome 2mg/kg on days 1, 2, 3, 4, 5, 6, and 10 (total dose 14 mg/kg); group 2 received AmBisome 2 mg/kg on days 1, 2, 3, 4, and 10 (total dose 10 mg/kg); group 3 received the same dosage on 1, 5 and 10 (total dose 6 mg/kg). Clinical cure resulted in all patients by day 24. Haemoglobin, white blood cell count, body weight and serum albumin level improved on day 24 and became normal by day 180. No patient relapsed within 12 months of follow-up. Side effects were minimal. One patient in group 2 died after 2 months from an unrelated disease. Liposomal amphotericin B is a promising new drug which is highly efficacious in the treatment of Indian kala-azar and produces minimal toxicity.

• Authors: C P Thakur, A K Pandey, G P Sinha, S Roy, K Behbehani, P Olliaro
• Journal: Transactions of the Royal Society of Tropical Medicine and Hygiene (Trans R Soc Trop Med Hyg) 1996 May-Jun Vol. 90 Issue 3 Pg. 319-22 ISSN: 0035-9203 [Print] England
• PMID: 8758093 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiprotozoal Agents
• Drug Carriers
• Liposomes
• liposomal amphotericin B
• Amphotericin B

Topics

• Adult
• Amphotericin B (adverse effects, therapeutic use)
• Animals
• Antiprotozoal Agents (adverse effects, therapeutic use)
• Drug Carriers
• Female
• Humans
• India
• Leishmania donovani
• Leishmaniasis, Visceral (drug therapy)
• Liposomes
• Male
• Prospective Studies
• Treatment Outcome