Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir- experienced subjects: AIDS Clinical Trials Group protocol 373

Citation
Rm. Gulick et al., Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir- experienced subjects: AIDS Clinical Trials Group protocol 373, J INFEC DIS, 183(5), 2001, pp. 715-721
Citations number
25
Categorie Soggetti
Clinical Immunolgy & Infectious Disease",Immunology
Journal title
JOURNAL OF INFECTIOUS DISEASES
ISSN journal
00221899 → ACNP
Volume
183
Issue
5
Year of publication
2001
Pages
715 - 721
Database
ISI
SICI code
0022-1899(20010301)183:5<715:INSALF>2.0.ZU;2-O
Abstract
This prospective, multicenter, open-label study was designed to determine t he antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavi r 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 cha nged 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 <greater than or equal to>50 0 copies/mL) and CD4 cell counts increased by 94 cells/mm(3) 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 ac hieved subsequent durable virologic suppression.