8th Conference on Retroviruses and Opportunistic Infections Chicago, IL - February 4 - 8, 2001

Conf Retroviruses Opportunistic Infect 2001 Feb 4-8; 8:53 (abstract no. 33)

F. Laguna¹, S. Videla², E. Jimenez-Mejias³, G. Sirera⁴, J. Torres-Cisneros⁵, E. Ribera⁶, and J. Alvar⁷on behalf of the Spanish HIV-Leishmania Study Group.
¹Ctr. Natl. de Investigación Clín., Madrid; ²Lab. Dr. Esteve, Barcelona; ³Hosp. Virgen Rocío, Sevilla; ⁴Hosp.GermansTrias i Pujol, Badalona; ⁵Hosp. Reina Sofía, Córdoba;⁶Hosp. Vall d'Hebron, Barcelona; and⁷Ctr. Natl. de Microbiología, Majadahonda, Spain.

BACKGROUND: Visceral leishmaniasis (VL) is common in patients with HIV infection living in endemic areas, but the most effective and safe treatment remains unknown. The aim of this study was to compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate (MA) in HIV-infected patients with a first episode of VL.

METHODS: Study: multicentre, open-label with blinded centralised randomisation, parallel, active-controlled clinical trial. Setting: thirteen university general hospitals. Patients: HIV-infected patients with first episode of VL (confirmed by bone marrow aspirate) were randomised to receive either ABLC 3 mg/kd/d for 5 days (ABLC-5), ABLC 3 mg/kd/d for 10 days (ABLC-10), or MA 20 mg/kg/g (pentavalent antimony) for 28 days (MA-28). Treatment was considered successful if no parasites were detected in a bone marrow aspirate performed 1 month after the end of therapy. The primary analysis was performed following an intention-to-treat principle.

RESULTS: Fifty-seven patients were included in the study (18 ABLC-5; 20 ABLC-10, 19 MA-28). The efficacy (% of treatment success and 95% confidence interval) was similar for all treatments: 33.3% (13.3%-59.0%) for ABLC-5, 42.1% (20.3%-66.5%) for ABLC-10 and 36.8% (16.3%-61.6%) for MA-28. MA was worse tolerated than ABLC: in eight of 19 patients the treatment was withdrawn due to adverse events (including three deaths), 5 of them being treatment-related. ABLC presented mainly mild effects in relation with its administration, and no patient had to stop treatment administration.

CONCLUSIONS: ABLC administered 5 or 10 days presents an efficacy similar to that of MA administered for 28 days, with a lower frequency of adverse events and better tolerability. Treatment related adverse events leading to discontinuation were more frequent in the MA group than in ABLC groups.

2001-02-04
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