Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus type 1-infected protease inhibitor-experienced patients

Constance A. Benson, Steven G. Deeks, Scott C. Brun, Roy M. Gulick, Joseph J. Eron, Harold A. Kessler, Robert L. Murphy, Charles Hicks, Martin King, David Wheeler, Judith Feinberg, Richard Stryker, Paul E. Sax, Sharon Riddler, Melanie Thompson, Kathryn Real, Ann Hsu, Dale Kempf, Anthony J. Japour, Eugene Sun

Research output: Contribution to journalArticle

139 Scopus citations

Abstract

The safety and antiviral activity of lopinavir (Lpv), a protease inhibitor (PI) coformulated with ritonavir (Rtv) to enhance its pharmacokinetic properties, were evaluated in 70 patients with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000-100,000 copies/mL on a first PI-containing regimen. Patients were randomized to substitute only the PI with Lpv/Rtv, 400/100 mg or 400/200 mg twice daily. On day 15, nevirapine (200 mg 2x/day) was added, and nucleoside reverse-transcriptase inhibitors were changed. Despite a >4-fold reduction in phenotypic susceptibility to the preentry PI in 63% of patients, mean plasma HIV-1 RNA levels declined by 1.14 log10 copies/mL after 2 weeks of Lpv/Rtv. At week 48, 86% of subjects receiving treatment had plasma HIV-1 RNA levels of <400 copies/mL; 76% had levels <50 HIV-1 RNA copies/mL (intent-to-treat: 70% and 60%, respectively). Mean CD4 cell counts increased by 125 cells/

Original languageEnglish (US)
Pages (from-to)599-607
Number of pages9
JournalJournal of Infectious Diseases
Volume185
Issue number5
DOIs
StatePublished - Mar 1 2002

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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    Benson, C. A., Deeks, S. G., Brun, S. C., Gulick, R. M., Eron, J. J., Kessler, H. A., Murphy, R. L., Hicks, C., King, M., Wheeler, D., Feinberg, J., Stryker, R., Sax, P. E., Riddler, S., Thompson, M., Real, K., Hsu, A., Kempf, D., Japour, A. J., & Sun, E. (2002). Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus type 1-infected protease inhibitor-experienced patients. Journal of Infectious Diseases, 185(5), 599-607. https://doi.org/10.1086/339014