Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group study 359
Rm. Gulick et al., Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group study 359, J INFEC DIS, 182(5), 2000, pp. 1375-1384
This study compared antiretroviral activity among 6 "salvage" therapy regim
ens. The study was a prospective, randomized, 2 X 3 factorial, multicenter
study of the AIDS Clinical Trials Group. The study enrolled 277 human immun
odeficiency virus (HIV)-infected patients naive to nonnucleoside analogues
who had taken indinavir >6 months. The patients had 2000-200,000 HIV RNA co
pies/mL, Patients received saquinavir with ritonavir or nelfinavir together
with delavirdine and/or adefovir and were followed for safety and antiretr
oviral response between baseline and week 16, At week 16, 30% (77/254) of p
atients had less than or equal to 500 HIV RNA copies/mL, Virologic response
did not differ significantly between pooled ritonavir and nelfinavir group
s (28% vs. 33%; P = .50) or between pooled delavirdine and delavirdine/adef
ovir groups (40% vs. 33%; P = .42), Pooled delavirdine groups had a greater
virologic response rate than did adefovir groups (40% vs. 18%; P = .002),
Overall, one-third of patients who experienced virologic failure on an indi
navir-containing regimen suppressed virus load levels while they were takin
g a new salvage regimen.