Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS clinical trials group protocol 373

Roy M. Gulick, Laura M. Smeaton, Richard T. D’Aquila, Joseph J. Eron, Judith S. Currier, John G. Gerber, Edward Acosta, Jean Pierre Sommadossi, Roger Tung, Sally Snyder, Daniel R. Kuritzkes, Robert L. Murphy, Bruce Cohen, Joyce Drury, Baiba Berzins, Debra Johnson, Virgilio Clemente, Karen Cavanagh, Michelle Phillip, Ernesto G. ScerpellaAllan E. Rodriguez, Michael K. Klebert, Pablo Tebas, M. Graham Ray, Sally Canmann, Melody Pratt-Palmore, Sherree Wright, Timothy Cooley, Carolyn Koziol, Ian Frank, Christopher Helker, Linh Ngo, Nazneen Howerton, Wende Levy, Antoinette Kenton, Diane Daria, John Ioannidis, Elizabeth Adams, Ana Martinez, Anne Kmack, Mary Jo Werder, Jules Levin, Robert Curry, Marita McDonough, Patrick Robinson, Michael Stevens, Michael Rogers, Daniel Stein, Randi Leavitt, Melissa Seniuk, John Alam, Pravin Chaturvedi, Judith Partaledis

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Abstract

This prospective, multicenter, open-label study was designed to determine the antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavir every 8 h with 200 mg nevirapine, 40 mg stavudine, and 150 mg lamivudine, each given twice daily in amprenavir-experienced subjects. The primary end points of the study were the human immunodeficiency virus (HIV) RNA level and CD4 cell count responses. Fifty-six subjects were enrolled and were changed from amprenavir-containing regimens to the 4-drug regimen. Overall, at week 48, 33 (59%) of 56 subjects had HIV RNA levels <500 copies/mL (intent-to-treat analysis, where missing values equal ≥500 copies/mL) and CD4 cell counts increased by 94 cells/mm3 from baseline. Subjects who had previously taken amprenavir combination therapy were more likely to experience virologic failure than those who had taken amprenavir monotherapy (odds ratio, 7.7; P = .0012). In this study, most subjects who had taken amprenavir-based regimens and who changed to a 4-drug regimen achieved subsequent durable-virologic suppression.

Original languageEnglish (US)
Pages (from-to)715-721
Number of pages7
JournalJournal of Infectious Diseases
Volume183
Issue number5
DOIs
StatePublished - Mar 2001

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ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Gulick, R. M., Smeaton, L. M., D’Aquila, R. T., Eron, J. J., Currier, J. S., Gerber, J. G., Acosta, E., Sommadossi, J. P., Tung, R., Snyder, S., Kuritzkes, D. R., Murphy, R. L., Cohen, B., Drury, J., Berzins, B., Johnson, D., Clemente, V., Cavanagh, K., Phillip, M., ... Partaledis, J. (2001). Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS clinical trials group protocol 373. Journal of Infectious Diseases, 183(5), 715-721. https://doi.org/10.1086/318820