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