Amphotericin B lipid complex versus no treatment in the secondary prophylaxis of visceral leishmaniasis in HIV-infected patients.

Author(s): Lopez-Velez R, Videla S, Marquez M, Boix V, Jimenez-Mejias ME, Gorgolas M, Arribas JR, Salas A, Laguna F, Sust M, Canavate C, Alvar J, Spanish HIV-Leishmania Study Group

Affiliation(s): Enfermedades Infecciosas, Hospital Ramon y Cajal, Carretera de Colmenar, km 9.100, 28034-Madrid, Spain. rlopezvelez.hrc@salud.madrid.org

Publication date & source: 2004-03, J Antimicrob Chemother., 53(3):540-3. Epub 2004 Jan 22.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVES: Visceral leishmaniasis (VL) in HIV-positive patients is characterized by a chronic course with frequent relapse. The aim of this study was to evaluate the efficacy and safety of amphotericin B lipid complex (ABLC) in preventing VL relapses in HIV-infected patients. METHODS: This was a multicentre, open-label (with blinded centralized randomization), parallel, no-treatment, controlled clinical trial. HIV-infected patients, with at least one previous treated episode of VL and with negative bone marrow aspirate for Leishmania parasites prior to the study, were randomized to receive either ABLC 3 mg/kg/day every 21 days (ABLC) or no treatment (NT). Patients were followed-up every 9 weeks for up to 12 months, and the efficacy was measured as the proportion of patients remaining free (non-relapse) of VL at 1 year of follow-up. The primary analysis was performed on an intention-to-treat basis. RESULTS: One hundred and fifteen patients were screened, but only 17 were randomized: eight in the ABLC group and nine in the NT group. The intention-to-treat analysis of data showed 50% of patients remaining free of VL at 12 months of follow-up (95% CI = 15.7%, 84.3%) in the ABLC group, and 22.2% (95% CI = 2.8%, 60.0%) in the NT group. The non-relapse odds ratio was 3.5 (95% CI = 0.30%, 52.0%) favouring ABLC. ABLC was well tolerated: patients only presented infusion-related mild adverse events. No patients from either group discontinued treatment or died during follow-up. CONCLUSIONS: ABLC, administered every 21 days for 12 months, is useful as secondary prophylaxis in preventing VL relapse in HIV-infected patients, and is well tolerated.