TITLE

Once-Daily versus Twice-Daily Lopinavir/Ritonavir in Antiretroviral-Naive HIV-Positive Patients: A 48-Week Randomized Clinical Trial

AUTHOR(S)
Eron, Joseph J.; Feinberg, Judith; Kessler, Harold A.; Horowitz, Harold W.; Witt, Mallory D.; Carpio, Felix F.; Wheeler, David A.; Ruane, Peter; Mildvan, Donna; Yangco, Bienvenido G.; Bertz, Richard; Bernstein, Barry; King, Martin S.; Sun, Eugene
PUB. DATE
January 2004
SOURCE
Journal of Infectious Diseases;1/15/2004, Vol. 189 Issue 2, p265
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The safety, pharmacokinetics, and antiviral activity of lopinavir, a human immunodeficiency virus (HIV) protease inhibitor, coformulated with ritonavir as a pharmacokinetic enhancer were evaluated in 38 antiretroviral-naive patients randomized 1:1 to receive open-label lopinavir/ritonavir at a dose of 800/200 mg once daily or 400/100 mg twice daily, each in combination with stavudine and lamivudine twice daily, for 48 weeks. Over the course of 48 weeks, median predose concentrations of lopinavir exceeded the protein-binding corrected concentration required to inhibit replication of wild-type HIV by 50% in vitro by 40- and 84-fold in the once-and twice-daily groups, respectively. Predose concentrations of lopinavir were more variable in the once-daily group (mean ± SD, 3.62 ± 3.38 μg/mL for the once-daily group and 7.13 ± 2.93 μg/mL for the twice-daily group). At week 48, in an intent-to-treat (missing = failure) analysis, 74% of patients in the once-daily group and 79% of patients in the twice-daily group had HIV RNA levels of <50 copies/mL (P = .70). Study drug- related discontinuations occurred in 1 patient in each treatment group. Genotypic resistance testing of 4 patients with HIV RNA levels >400 copies/mL between weeks 24 and 48 demonstrated no protease inhibitor- resistance mutations.
ACCESSION #
11977952

 

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