Treatment of visceral leishmaniasis in HIV-infected patients: a randomizedtrial comparing meglumine antimoniate with amphotericin B

Background: Visceral leishmaniasis is common in patients with HIV infection living in endemic areas, but the most effective and safe treatment remains unknown. Objective: To compare the efficacy and safety of meglumine antimoniate vers us amphotericin B in HIV-infected patients with first episodes of visceral leishmaniasis (VL). Design: An open, multicentre, prospective and randomized trial. Setting: Twelve tertiary hospitals. Patients: Eighty-nine consecutive HIV-infected patients diagnosed with VL. Patients were randomly assigned to treatment with either meglumine antimoni ate (20 mg pentavalent antimony per kilogram of body weight per day) or amp hotericin B (0.7 mg/kg per day) both for 28 days. Treatment was considered successful if a bone marrow aspirate performed 1 month after the end of the rapy did not detect parasites. Relapse was defined as the reappearance of p arasites after an initial cure. Results: An initial cure was attained in 29 of 44 patients (65.9%) randomly assigned to treatment with meglumine antimoniate and 28 of 45 (62.2%) rand omly assigned to treatment with amphotericin B. The incidence of moderate t o severe adverse events was similar in both groups. The patients treated wi th meglumine antimoniate had higher incidences of cardiotoxicity (14 versus 0%, P = 0.02) and chemical pancreatitis (30 versus 0%, P < 0.01). However, in the amphotericin B group, nephrotoxicity was more frequent (36 versus 5 %, P < 0.01). There was no difference in survival or relapse-free interval according to the allocated group of therapy. Conclusion: Treatment of VL with meglumine antimoniate or amphotericin B wa s shown to have similar efficacy and toxicity rates in Spanish HIV-infected patients. The differences in the toxicity patterns could be useful in choo sing one of these agents as first-line treatment. (C) 1999 Lippincott Willi ams & Wilkins.