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| |  WORLD AIDS CONFERENCE: Leukine Reduces Viral Load In AIDS Patients, Researchers Say SEATTLE, WA -- June 30, 1998 -- Researchers at the 12th World AIDS Conference reported today that patients who received Immunex Corp.’s Leukine(R) (sargramostim) in addition to either AZT alone or in combination with another nucleoside analog, experienced reductions in viral load. Today's findings were from a six-month, phase III clinical trial involving 105 patients with AIDS who had CD4+ T cell counts of less than 300. Viral load is an important marker used by physicians and patients to monitor HIV disease progression. The research reported today is part of a clinical development program to study Leukine, an immunomodulator, as a potential adjunctive AIDS therapy. The research was conducted at the Federal University of Bahia in Salvador, Brazil. Patients in the study received subcutaneous injections of Leukine twice a week, in addition to AZT monotherapy or combination nucleoside analog therapy. At the end of six months, median viral load was reduced -.52 log10 in the Leukine group as compared to -0.1 log10 in the placebo group. This represents a 69 percent reduction in viral load among patients receiving Leukine as compared to a two percent reduction in the placebo group. Further, more individuals treated with Leukine experienced a 90 percent or greater reduction in viral load while on study (43 percent versus 16 percent.) "An interesting trend in this study was that for some patients, the addition of Leukine led to what the medical community views as undetectable levels of viral load," said Roberto Badaro, MD, professor of infectious diseases, Federal University of Bahia, Brazil, president of The Brazilian Society of Infectious Diseases and visiting professor of The Harvard School of Tropical Medicine and Hygiene. "Viral load was reduced to less than 500 copies/ml in 19 percent of the Leukine patients as compared to five percent of the placebo group." In addition, more individuals receiving Leukine experienced an increase of 30 percent or more in CD4+ T cells during therapy (80 percent versus 58 percent). CD4+ T cells are crucial immune system cells that fight disease and infection which are progressively depleted by HIV. A healthy person without HIV infection has about 1,200 CD4+ T cells -- patients entering this trial had less than 300. Among the most at-risk patients, the subset with CD4+ T cell counts of 50 or less at baseline, 60 percent of those receiving Leukine had no opportunistic infection during the six-month study, as compared to 37 percent of the placebo group. This finding was despite the fact that many of the patients on the Leukine arm had prior opportunistic infections and a lower CD4+ T cell count. The incidence of opportunistic infections in patients with CD4+ T cell counts greater than 50 was not different between groups. The most frequently reported adverse event was anemia, occurring at a similar rate in both the Leukine and placebo groups. The study was a six-month, Phase III, double-blind, randomised, placebo-controlled trial involving 105 patients with AIDS who had CD4+ T cell counts of less than 300. Patients received either 125mcg/m2 of Leukine or a placebo, twice weekly, subcutaneous injections in combination with AZT monotherapy or combination nucleoside analog therapy (35 patients received AZT and 70 patients received AZT in combination with a second nucleoside analog). More information on: Leukine, AZT, Immunex Corp.
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