JAC Advance Access published online on January 22, 2004
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkh084
© 2004 by The British Society for Antimicrobial Chemotherapy
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Brief report
1 Enfermedades Infecciosas,
Hospital Ramón y Cajal, Carretera de Colmenar, km 9.100,
28034-Madrid;
* Corresponding author. E-mail: rlopezvelez.hrc{at}salud.madrid.org.
Received 12 September 2002
; 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
Amphotericin B lipid complex versus no treatment
in the secondary prophylaxis of visceral leishmaniasis in HIV-infected
patients
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
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