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

J Antimicrob Chemother. 2004 Mar;53(3):540-3. doi: 10.1093/jac/dkh084. Epub 2004 Jan 22.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amphotericin B / administration & dosage
  • Amphotericin B / adverse effects
  • Amphotericin B / therapeutic use*
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / adverse effects
  • Antifungal Agents / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Female
  • HIV Infections / complications*
  • Humans
  • Leishmaniasis, Visceral / parasitology
  • Leishmaniasis, Visceral / prevention & control*
  • Male
  • Phosphatidylcholines / administration & dosage
  • Phosphatidylcholines / adverse effects
  • Phosphatidylcholines / therapeutic use*
  • Phosphatidylglycerols / administration & dosage
  • Phosphatidylglycerols / adverse effects
  • Phosphatidylglycerols / therapeutic use*


  • Antifungal Agents
  • Drug Combinations
  • Phosphatidylcholines
  • Phosphatidylglycerols
  • liposomal amphotericin B
  • Amphotericin B