Philip C. Johnson, MD; L. Joseph Wheat, MD; Gretchen A. Cloud, MS; Mitchell Goldman, MD; Dan Lancaster, MD; David M. Bamberger, MD; William G. Powderly, MD; Richard Hafner, MD; Carol A. Kauffman, MD; William E. Dismukes, MD; U.S. National Institute of Allergy and Infectious Diseases Mycoses Study Group*
Johnson PC, Wheat LJ, Cloud GA, Goldman M, Lancaster D, Bamberger DM, et al. Safety and Efficacy of Liposomal Amphotericin B Compared with Conventional Amphotericin B for Induction Therapy of Histoplasmosis in Patients with AIDS. Ann Intern Med. 2002;137:105-109. doi: 10.7326/0003-4819-137-2-200207160-00008
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Published: Ann Intern Med. 2002;137(2):105-109.
In patients with moderate to severe histoplasmosis associated with AIDS, the preferred treatment has been the deoxycholate formulation of amphotericin B. However, serious side effects are associated with use of amphotericin B.
To compare amphotericin B with liposomal amphotericin B for induction therapy of moderate to severe disseminated histoplasmosis in patients with AIDS.
Randomized, double-blind, multicenter clinical trial.
21 sites of the U.S. National Institute of Allergy and Infectious Diseases Mycoses Study Group.
81 patients with AIDS and moderate to severe disseminated histoplasmosis.
Clinical success, conversion of baseline blood cultures to negative, and acute toxicities that necessitated discontinuation of treatment.
Clinical success was achieved in 14 of 22 patients (64%) treated with amphotericin B compared with 45 of 51 patients (88%) receiving liposomal amphotericin B (difference, 24 percentage points [95% CI, 1 to 52 percentage points]). Culture conversion rates were similar. Three patients treated with amphotericin B and one treated with liposomal amphotericin B died during induction (P = 0.04). Infusion-related side effects were greater with amphotericin B (63%) than with liposomal amphotericin B (25%) (P = 0.002). Nephrotoxicity occurred in 37% of patients treated with amphotericin B and 9% of patients treated with liposomal amphotericin B (P = 0.003).
Liposomal amphotericin B seems to be a less toxic alternative to amphotericin B and is associated with improved survival.
*For a list of study investigators and numbers of patients enrolled, see Appendix.
Amphotericin B is the preferred initial treatment for moderate to severe disseminated histoplasmosis. Because amphotericin B has many serious side effects, alternative treatments are needed.
This double-blind, multicenter trial compared liposomal amphotericin B with regular amphotericin B in patients with disseminated histoplasmosis and AIDS. Liposomal amphotericin B had a higher treatment response (88% vs. 64%) and lower mortality rates (2% vs. 13%). It also had fewer infusion-related side effects (25% vs. 63%) and less nephrotoxicity (9% vs. 37%).
Although expensive, liposomal amphotericin B is better than regular amphotericin B for treating severe disseminated histoplasmosis.
. Time to clinical response, as defined by defervescence, for patients with a temperature higher than 37.8 °C 1 day before or at baseline. value for clinical response, defined by defervescence, was 0.09 using the log-rank test. . Survival during induction therapy. value for survival during induction therapy was 0.04 using the log-rank test.
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