Amphotericin B lipid complex versus meglumine antimoniate in the treatment of visceral leishmaniasis in patients infected with HIV: a randomized pilot study

Abstract

Optimal treatment for HIV-related visceral leishmaniasis (VL) has still to be established. A pilot clinical trial was carried out in 57 HIV-VL coinfected patients to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate. The patients were randomized to receive either ABLC 3 mg/kg/day for 5 days (ABLC-5, 18 patients), ABLC 3 mg/kg/day for 10 days (ABLC-10, 20 patients) or meglumine antimoniate 20 mg Sbv /kg/day for 28 days (19 patients). Treatment was considered successful if parasites were not detected in a bone marrow aspirate after treatment. Parasitological cure was attained in 33% (95% CI: 13%-59%) of the ABLC-5 group, in 42% (95% CI: 16%-62%) of the ABLC-10 group and in 37% (95% CI: 16%-62%) of the meglumine antimoniate group (P = 0.94). Eight out of 19 patients administered antimoniate discontinued treatment prematurely following serious adverse events, compared with one in the ABLC groups (P = 0.0006). The efficacy of ABLC is similar to meglumine antimoniate, but the severity of toxicity in the treatment of HIV-VL is lower with ABLC.

The Relationship between Leishmaniasis and AIDS: the Second 10 Years

“…Optimal treatment regimens have yet to be established for any region. A parasitological response to treatment is not indicative of an absence of future relapses (134,135,189), while a clinical response does not necessarily indicate parasitological clearance (141). Because recovery without relapses in immunodepressed patients has not yet been achieved, secondary prophylaxis must be considered, but there is little evidence of its efficacy.…”

Drug Resistance in Leishmaniasis

“…Irrespective of the findings of the experimental models, it is now known that intact immunity holds the key to the curative ability of antileishmanial drugs, including amphotericin B. Experiences with HIV/VL coinfection in the Mediterranean region, most frequently caused by L. infantum, suggest that CD4-deficient individuals tend to relapse frequently (90). In randomized controlled trials in Spain, cure rates in both antimonial-and amphotericin B-treated coinfected patients were as low as 66% and 62%, respectively, compared with Ͼ90% cure rates in non-HIV patients (89).…”

Liposomal systems as carriers for bioactive compounds

“…Not only do trusted treatments cause many side-effects in patients, but there is still the problem of parasites developing resistance to the drugs (Kaur and Rajput 2014). In addition, there is a lack of knowledge regarding the action mechanism of the drugs, and current treatment regimens are expensive (Alvar et al 1997;Laguna et al 2003;Chakravarty and Sundar 2010;Kaur and Rajput 2014).…”

“…This system has the potential to become a first-line drug in the treatment of visceral leishmaniasis (VL), but its high cost currently limits its use (Alvar et al 1997;Laguna et al 2003). This formulation also has a longer half-life time, which reduces the possibility of the emergence of resistance .…”