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Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines
Date:8/5/2008

e similar. In addition, the proportions of whites and non-whites who achieved an undetectable HIV viral load were similar. Specifically, 72 percent of women and 78 percent of men, and 75 percent of non-whites and 77 percent of whites had undetectable HIV viral loads (less than 50 copies/mL) at 48 weeks.

CD4+ cell count mean increases over 48 weeks were similar for females and males, independent of baseline CD4+ cell count, except among women with baseline CD4+ cell counts of fewer than 50 cells/mm3, who experienced statistically significant greater mean increases in CD4+ cell counts than males. In addition, CD4+ cell count mean increases over 48 weeks were similar for whites and non-whites. At 48 weeks, the overall rate of moderate to severe and related adverse events of diarrhea was 15.8 percent. A similar rate of diarrhea was observed in whites (17.8 percent), while non-whites experienced a rate of 9.7 percent.

"This sub-analysis of M05-730 provides additional clinical information on race and gender response with Kaletra," said Joseph Gathe, Jr., M.D., clinical instructor, Department of Internal Medicine, Baylor College of Medicine. "The information can help physicians in making treatment decisions for the patient populations most affected by HIV."

About the M05-730 Study -- 48-week Data

Design and Primary Endpoints:

-- M05-730 study is a 96-week Phase III open-label, randomized, multi-center, multi-country study that enrolled 664 ARV-naive patients with HIV-1 RNA >1000 copies/mL and any CD4+ T-cell count. Patients were randomized equally to lopinavir/ritonavir 800/200 mg once-daily soft gel capsule (SGC), 400/100 mg twice-daily (BID) SGC, 800 mg/200 mg once-daily tablet or 400/100 mg twice-daily tablet for eight weeks. All patients also received emtricitabine (FTC) 200 mg once-daily and tenofovir disoproxil fumarate 300 mg once-daily. At week eight, all patients receiving SGC were switched to the tablet formulation of Kaletra, m
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SOURCE Abbott
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