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.

Response to treatment with organic pentavalent antimonials, the standard first-line treatment for visceral leishmaniasis (VL), has been decreasing since their introduction into India. Combining sodium stibogluconate (SB) with paromomycin (PM) may be an efficient alternative to single-agent therapy. This trial was designed to assess the safety and efficacy of PM 12 or 18 mg/kg daily plus SB 20 mg/kg daily for 21 days compared to SB alone for 30 days. One hundred and fifty patients were randomly assigned in 1996 to 1 of the 3 treatments and followed-up for 180 days. At the end of treatment, 49 of 52 patients receiving PM12 + SB, 46 of 48 receiving PM18 + SB, and 27 of 49 patients receiving SB alone, were cured. During follow-up there was 1 relapse in each of the treatment groups, giving final cure rates of 48 of 52 (92.3%) for PM12 + SB, 45 of 48 (93.8%) for PM18 + SB, and 26 of 49 (53.1%) for SB. PM plus SB for 21 days at either 12 or 18 mg/kg daily was significantly more effective than SB alone for 30 days (chi 2 P < 0.001). One patient (SB alone) had experienced a serious adverse event: cardiotoxicity at day 8 (myocarditis and ECG changes) which caused withdrawal from the study. Only 19 of 100 patients enrolled in the PM treatment arms had a complete audiogram series conducted thus making it difficult to assess oto-toxicity. PM 12 or 18 mg/kg daily plus a standard dose of SB for 21 days was statistically more effective than SB in producing a final cure for patients with VL in Bihar, India.

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Fifty children in the first decade of life, and suffering from multiple drug resistant kala-azar, confirmed by demonstration of amastigotes in aspirates of bone marrow or spleen were treated with amphotericin B in gradually increasing dosage to a total dose of 20 mg/kg. All patients had classical features of severe kala-azar, and had taken more than one course of antimony and pentamidine, and three patients had taken one additional course of ketoconazole besides many courses of antimony and pentamidine. The clinical response started just after first infusion in 8 patients, and the patients became afebrile. By 5th infusion, all looked better and 18 patients became afebrile. By 15th infusion all patients were afebrile and cheerful. Their spleens became smaller and body weights and total white cell counts increased. Forty eight patients had parasitological cure at the end of treatment, and only 2 patients required an additional 5 infusions for parasitological cure. All patients were ultimately cured. No one relapsed within six months of follow up. All patients had shivering, rigor and rise of temperature on the day of infusion, which could be minimized with prior administration of low dose of hydrocortisone, but could not be eliminated. Eighteen patients had loose motions during treatment, while 14 patients had decrease in appetite which improved quickly when the treatment was over. Fourteen patients had transient rise of blood urea, in six patients serum creatinine also increased and 16 patients had a minor fall in serum potassium.(ABSTRACT TRUNCATED AT 250 WORDS)