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JAC Advance Access originally published online on January 22, 2004
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Journal of Antimicrobial Chemotherapy (2004) 53, 540-543
© 2004 The British Society for Antimicrobial Chemotherapy

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

Rogelio López-Vélez1,*, Sebastián Videla2, Manuel Márquez3, Vicente Boix4, Manuel E. Jiménez-Mejías5, Miguel Górgolas6, José R. Arribas7, Ana Salas8, Fernando Laguna9, Mariano Sust2, Carmen Cañavate10 and Jorge Alvar10 on behalf of the Spanish HIV-Leishmania Study Group§

1 Enfermedades Infecciosas, Hospital Ramón y Cajal, Carretera de Colmenar, km 9.100, 28034-Madrid; 2 Laboratorios Dr Esteve, Barcelona; 3 Hospital Virgen de la Victoria, Málaga; 4 Hospital General, Alicante; 5 Hospital Virgen del Rocío, Sevilla; 6 Fundación Jiménez-Díaz, Madrid; 7 Hospital La Paz, Madrid; 8 Hospital Son Dureta, Palma de Mallorca; 9 Hospital Carlos III, Madrid; 10 Centro Nacional Microbiología, Majadahonda, Spain

Received 12 September 2002; returned 7 March 2003; revised 26 September 2003; accepted 17 November 2003

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.

Keywords: leishmaniasis, HIV, amphotericin B, clinical trial with blinded centralized randomization

* Corresponding author. Tel: +34-91-336-81-08; E-mail: rlopezvelez.hrc{at}salud.madrid.org

§ Members of the Spanish HIV-Leishmania Study Group are listed in the Acknowledgements.


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