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Home > Scientific articles
Jun 2024

A phase II, non-comparative randomised trial of two treatments involving liposomal amphotericin B and miltefosine for post-kala-azar dermal leishmaniasis in India and Bangladesh

PLOS Neglected Tropical Diseases

by Sundar S, Pandey K, Mondal D, Madhukar M, Kamal Topno R, Kumar A, Kumar V, Kumar Verma D, Chakravarty J, Chaubey R, Kumari P, Rashid U, Maruf S, Ghosh P, Raja S, Rode J, den Boer M, Das P, Alvar J, Rijal S, Alves F. PLOS Neglected Tropical Diseases 2024, 18(6): e0012242. doi: 10.1371/journal.pntd.0012242

Summary: Post-kala-azar dermal leishmaniasis (PKDL) plays a role in the transmission of visceral leishmaniasis. Within the Southeast Asia kala-azar elimination initiative, all patients with PKDL are treated, but it is difficult to justify using the existing prolonged, and potentially toxic, treatments in people who are otherwise well. We assessed the efficacy and safety of 20 mg/kg liposomal amphotericin B in monotherapy and in combination with three weeks of miltefosine in an open-label, phase II, randomized, parallel-arm, non-comparative trial in India and Bangladesh. These two regimens had similar efficacy to the current first-line treatment, but with a much shorter treatment duration, reducing the risk of side-effects and making them particularly useful in the context of elimination in the region.

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Clinical trials Visceral leishmaniasis Asia Bangladesh India

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