Brites C, Badaro R, Pedral-Sampaio D, Bahia F, Pedroso C, Alcantara AP, Stellrecht K, Sasaki M, Matos J, Mongillo A, Whitmore J, Gilbert M; Interscience Conference on Antimicrobial Agents and Chemotherapy.

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1998 Sep 24-27; 38: 440 (abstract no. I-243).

Federal University of Bahia, Salvador, Brazil.

GM-CSF has been shown to increase CD4 cell counts in HIV+ individuals receiving AZT. To determine the effect on viral load (VL) and opportunistic infections (Ols), a placebo controlled, double blind, Phase III study enrolled 105 individuals with AIDS (CD4<300), randomized to receive standard antiretroviral therapy and either 125 micrograms/m(2) of yeast-derived, full-length GMCSF (sargramostim) or placebo SQ twice weekly for 6 months. Subjects were evaluated at 1, 3 and 6 months for changes in VL, lymphocyte subsets and weekly for Ols. Thirty-five subjects received AZT 300 mg/day only; 70 received AZT and a second nucleoside analog during study. No significant differences between groups were observed in baseline VL, prior Ols, or the use of nucleoside analogs; however, baseline CD4 cell counts were significantly lower in the GM-CSF group (median 80 cells/microliter v. 137 cells/microliter; p = 0.029). Median changes in VL were -0.03 log10 for placebo and -0.15 log10 for GM-CSF at 1 month (p = 0.14), 0.00 log10 for placebo and -0.33 log10 for GM-CSF at 3 months (p = 0.06) and -0.01 log10 for placebo and -0.51 log10 for GM-CSF at 6 months (p = 0.02). VL fell below 400 copies/ml at 6 months in 17% of subjects on GM-CSF, v. 4% on placebo (p = 0.07). The GM-CSF group also had more individuals with > 0.5 log10 reduction in VL at multiple measurements (33% v 17%; p = 0.01) and more iridividuals with > 1.0 log10 reduction in VL (43%, v. 16%; p < 0.014. Change in absolute CD4 cell count was higher in the GM-CSF group at each time point, and more individuals had > 30% increase in CD4 cell count during therapy (80% v. 58%; p = 0.027). The incidence of Ols in GM-CSF-treated subjects was lower in the subset with baseline CD4 cell count < 50 (40% v. 63%); however, statistical significance was, limited by the small number of control subjects with low CD4 counts. No difference was observed between groups for Ols in subjects with CD4 cell count > 50, hospitalization, or death. Twice weekly Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• CD4 Lymphocyte Count
• Double-Blind Method
• Granulocyte Macrophage Colony-Stimulating Factors, Recombinant
• Granulocyte-Macrophage Colony-Stimulating Factor
• HIV Infections
• HIV Seropositivity
• Humans
• Incidence
• Placebos
• Viral Load
• Zidovudine
• organization & administration
• sargramostim

Other ID:

• 20711054

UI: 102188399

From Meeting Abstracts