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Home > Scientific articles
Feb 2022
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AmBisome monotherapy and combination AmBisome – miltefosine therapy for the treatment of visceral leishmaniasis in patients co-infected with HIV in India: A randomised open label, parallel arm, phase III trial

Clinical Infectious Diseases

by Burza S, Mahajan R, Kazmi S, Alexander N, Kumar D, Kumar V, Lasry E, Harshana A, de Lima Pereira A, Das P, Verma N, Nand Ravi Das V, Shekhar Lal C, Rewari B, Goyal V, Rijal S, Alves F, Gill N, Pandey K. Clinical Infectious Diseases 2022; ciac127. doi: 10.1093/cid/ciac127

Summary: Despite being an increasingly important patient cohort, evidence for treatment of visceral leishmaniasis in patients living with HIV is sparce, with no high-quality studies from the Indian sub-continent. The authors describe a clinical trial conducted in India comparing treatment using 40mg/kg intravenous liposomal amphotericin B over 28 days with 30mg/kg intravenous liposomal amphotericin B plus 1.4g oral miltefosine over 14 days in 150 adults infected with VL and living with HIV. Relapse free survival at day-210 was 85% in the monotherapy arm and 96% in the combination arm, which increased to 90% and 97%, respectively, when patients also infected with tuberculosis were excluded. The combination therapy appears to be safe, well tolerated and effective, with half the treatment duration of the currently recommended option

This article is an ‘accepted manuscript’ and is not yet in its final published form.

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Clinical trials Visceral leishmaniasis India

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